Tag Archive for: prostate cancer

Prostate cancer with kidney failure: is surgery, focal therapy or radiation the right choice?

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A patient guide by Dr Jo Schoeman

A diagnosis of prostate cancer is unsettling. Having chronic kidney disease or needing dialysis can make treatment decisions feel even harder. The reassuring point is that kidney failure does not automatically rule out treatment. The best choice depends on the cancer, the degree of kidney impairment, other medical conditions and, crucially, whether a kidney transplant is planned.

What does Gleason 3+4 mean?

Gleason 3+4=7 is Grade Group 2 prostate cancer. Most of the sampled tumour has pattern 3, with a smaller component of pattern 4. It is generally less concerning than Gleason 4+3=7, but “3+4” alone cannot tell us whether immediate treatment is needed.

I would review the PSA and PSA density, examination, MRI findings, number and length of positive biopsy cores, percentage of pattern 4, any cribriform or intraductal cancer, and whether disease is confined to the prostate. Kidney function, dialysis schedule, life expectancy and transplant eligibility are considered alongside these findings. Some men have favourable intermediate-risk cancer; others have features that make definitive treatment more appropriate. Staging scans are selected according to overall risk rather than biopsy grade alone. [1,2]

Could active surveillance be reasonable?

Yes, for selected men with small-volume, favourable Grade Group 2 cancer. Surveillance means scheduled PSA tests, clinical review, MRI where useful and repeat biopsy when indicated. It keeps treatment available if the cancer changes. It is a particularly meaningful option when another serious illness makes the harms of immediate treatment more likely to outweigh its benefit. It does, however, require a patient who can attend follow-up and accepts a small increased risk of progression compared with immediate treatment. [1,2]

If kidney disease or other illnesses substantially limit life expectancy, watchful waiting may be more appropriate: care focuses on symptoms rather than routine testing intended to trigger curative treatment. This is a separate decision from active surveillance. [1]

Can radical prostatectomy or robotic surgery be performed?

Often, yes. Chronic kidney disease and dialysis are not automatic contraindications to radical prostatectomy. Robotic assisted surgery may offer less blood loss and a shorter hospital stay than open surgery in selected patients, but it still involves general anaesthesia, abdominal insufflation and a head-down operating position. Advanced kidney disease increases the importance of planning for bleeding, infection, fluid and electrolyte balance, medication dosing and postoperative kidney injury. Population studies find higher complication rates in patients with chronic kidney disease, particularly advanced disease; individual risk varies considerably. [3,4]

Before an operation I would coordinate with the nephrologist, anaesthetist and, where relevant, dialysis team. We would assess cardiovascular health, haemoglobin, potassium, anticoagulants, residual kidney function and the timing of dialysis. Surgery also carries the usual risks of urinary leakage or incontinence, erectile dysfunction, infertility, blood clots and possible need for further cancer treatment. Whether a robotic approach is feasible depends on the patient and the surgical team; it is not automatically a safer choice for every person with kidney failure. [1,3,4]

Is focal therapy a better option?

Not simply because the kidneys are failing. Focal therapy treats the visible cancer-bearing portion of the prostate, using a technique such as focused ultrasound, cryotherapy or another ablative method. It may appeal to men hoping to reduce urinary or sexual side effects, but the cancer can be present elsewhere in the gland, and longer-term cancer control is less certain than for established whole-gland treatments. Further MRI, biopsies and sometimes repeat treatment are necessary.

The AUA/ASTRO guideline notes a lack of high-quality comparisons with surgery, radiation and surveillance. European guidance restricts focal treatment to settings with careful prospective follow-up, such as a trial or registry. Kidney disease alone does not establish that focal treatment is preferable. In a suitable patient it can be discussed with a specialist who explains uncertainty, access, costs and a clear follow-up plan. [1,2]

Is radiotherapy an option?

Yes. External beam radiotherapy avoids major surgery and usually does not expose the kidneys directly when treating a prostate confined to the pelvis. Options include moderately shortened courses and, for selected men, more condensed schedules or brachytherapy. The radiation oncologist will tailor treatment to the cancer and urinary function. Depending on whether the disease is favourable or unfavourable intermediate risk, a course of androgen deprivation therapy (ADT) may also be advised; ADT has its own effects on energy, muscle, bone and metabolic health. [1,2]

Radiotherapy may cause temporary urinary frequency, burning or bowel upset; longer-term urinary, bowel or erectile effects are also possible. Existing urinary obstruction and kidney transplant anatomy can change planning. In a transplant recipient, the graft and ureter may sit in the pelvis, so radiation dose constraints require particular attention. Dialysis, by itself, does not make prostate radiation impossible. [1,2]

What if a kidney transplant is planned?

This is a central part of the discussion. A transplant team may need to know whether the cancer is under surveillance or has been treated, its estimated risk of progression and the proposed follow-up. The presence of prostate cancer does not automatically mean that transplantation must wait for a fixed number of years; transplant eligibility is individual and should be discussed directly with the transplant team. A transplanted kidney in the pelvis also affects the planning of later pelvic surgery or radiotherapy. [5]

How do we decide?

Option When it may fit Main trade-off
Active surveillance Low-volume, favourable Grade Group 2 disease Regular testing and a possibility of later treatment
Robotic radical prostatectomy Fit patient seeking definitive local treatment Anaesthetic and surgical risks, with continence and erectile side effects
Radiotherapy Patient seeking definitive treatment without prostate removal Urinary, bowel and sexual effects; ADT may be needed
Focal therapy Carefully selected patient after discussion of uncertainty Less established long-term cancer control and ongoing biopsies
Watchful waiting Limited life expectancy or major competing health risks Treats symptoms if they arise rather than aiming for cure

There is no universal winner between robotic surgery and radiation for Gleason 3+4 cancer with kidney failure. A multidisciplinary discussion involving urology, radiation oncology, nephrology and the transplant team, if applicable, helps align cancer control with kidney health and the patient’s priorities.

This article offers general information and cannot determine treatment for an individual patient. Decisions require review of the pathology, imaging, kidney function and overall health.

References

  1. European Association of Urology. EAU Guidelines on Prostate Cancer: Treatment. Accessed September 2026.
  2. American Urological Association and American Society for Radiation Oncology. Clinically Localized Prostate Cancer Guideline. 2022.
  3. Post-surgical outcomes of patients with chronic kidney disease and end stage renal disease undergoing radical prostatectomy: 10-year results from the US National Inpatient Sample. 2019.
  4. The Effect of Chronic Kidney Disease on Adverse In-Hospital Outcomes at Radical Prostatectomy. 2025.
  5. Kidney Disease: Improving Global Outcomes. KDIGO Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation. 2020.

Tranexamic Acid for Radiation Cystitis: Benefits, Duration and Important Risks

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Blood in the urine after pelvic radiotherapy can be frightening. It may appear months or even many years after treatment for prostate, bladder, rectal or gynaecological cancer. One possible cause is radiation cystitis: delayed injury to the bladder lining and its small blood vessels.

Tranexamic acid is sometimes considered when bleeding is troublesome. It can help stabilise blood clots, but it does not repair the radiation injury itself and it is not suitable for every patient. In urinary tract bleeding, preventing a clot from dissolving may reduce bleeding but may also allow a larger clot to obstruct the bladder or ureter. Careful patient selection and medical supervision are therefore essential.

Seek urgent medical attention if you cannot pass urine, are passing large clots, feel faint or breathless, develop fever or flank pain, or the bleeding is heavy or worsening.

What is radiation cystitis?

Radiotherapy can cause progressive damage to the bladder’s small blood vessels. These vessels may become fragile and bleed easily. Patients may experience visible haematuria, urinary frequency, urgency, pain or recurrent clot retention.

Radiation cystitis should not be assumed simply because a patient has previously received radiotherapy. Infection, urinary stones, recurrent or new cancer, kidney disease and medication-related bleeding must also be considered. Assessment may include urine testing and culture, a full blood count, renal function, imaging of the upper urinary tract and cystoscopy. Biopsy is used selectively because irradiated tissue heals poorly.

How does tranexamic acid work?

The body normally breaks down blood clots through a process called fibrinolysis. Tranexamic acid blocks the binding of plasminogen and plasmin to fibrin, slowing this breakdown. It is therefore an antifibrinolytic medicine: it helps a clot remain in place rather than acting as a blood-clotting factor itself.

For radiation cystitis, tranexamic acid is intended to control active bleeding. It does not remove abnormal radiation-induced blood vessels, reverse fibrosis or prevent future bleeding once the medicine is stopped.

How effective is it for radiation cystitis?

The evidence is limited. Tranexamic acid has been used for haematuria from several causes, and a small randomised emergency-department study found that intravenous treatment reduced the amount of bladder irrigation required to clear the urine. However, it did not significantly reduce haemoglobin loss or transfusion requirements. Importantly, this study included mixed causes of haematuria and was not designed specifically for radiation cystitis.

The Canadian Urological Association best-practice report concluded that evidence was insufficient to make a formal recommendation for tranexamic acid in radiation-induced haemorrhagic cystitis. Later narrative reviews have reached a similar conclusion. Intravesical tranexamic acid, placed directly into the bladder, has shown encouraging results in small emergency-department studies of gross haematuria, but evidence specific to radiation cystitis is still inadequate and this remains a specialist, non-standard use.

In practice, tranexamic acid may be considered as a temporary adjunct in selected patients while the cause and severity of bleeding are assessed, or while more definitive treatment is arranged. It should not delay bladder washout, clot evacuation, cystoscopic treatment, hyperbaric oxygen therapy, embolisation or other appropriate care when these are required.

How long can tranexamic acid be used?

There is no well-supported universal duration for radiation cystitis. The Australian product information for oral tranexamic acid describes treatment of haematuria while blood remains macroscopically visible, but radiation cystitis is a recurrent condition and that instruction should not be interpreted as approval for indefinite therapy.

For this indication, treatment is generally best regarded as a short, medically supervised course for an active bleeding episode. The exact dose and duration depend on:

  • whether bleeding is mild, ongoing or causing clot retention;
  • whether the source is the bladder or upper urinary tract;
  • kidney function, because tranexamic acid is largely eliminated in the urine;
  • previous blood clots, cardiovascular risk and pro-thrombotic medicines;
  • anticoagulant or antiplatelet therapy; and
  • the response to treatment and need for definitive therapy.

There is no good evidence supporting continuous long-term tranexamic acid as prophylaxis for recurrent radiation cystitis. If bleeding has not clearly improved within a short course, recurs promptly after treatment, or requires repeated courses, the diagnosis and management plan should be reassessed. Longer or repeated use should occur only under specialist supervision, with renal function and thrombotic risk reviewed.

Patients should not start, extend, repeat or stop prescribed tranexamic acid without discussing it with their treating clinician.

Important side effects

Common or less serious adverse effects may include:

  • nausea, vomiting, diarrhoea or abdominal discomfort;
  • headache, dizziness or fatigue; and
  • muscle or joint discomfort.

Potentially serious adverse effects include:

Blood clots

Deep-vein thrombosis, pulmonary embolism, stroke, heart attack and other arterial or venous thromboses are uncommon but potentially serious. Risk assessment is particularly important in patients with an active or previous clot, known thrombophilia, active malignancy, prolonged immobility or concurrent pro-thrombotic medication.

Urgent assessment is required for new unilateral leg pain or swelling, sudden chest pain, shortness of breath, coughing blood, weakness on one side, difficulty speaking or sudden severe headache.

Clot retention and urinary obstruction

Tranexamic acid may stabilise clots within the urinary tract. This can contribute to painful bladder clot retention. It is particularly concerning when bleeding arises from a kidney or ureter, because a clot may obstruct the ureter and cause flank pain, hydronephrosis or loss of kidney function. Upper-tract haematuria therefore warrants particular caution and specialist assessment.

Kidney impairment

Most tranexamic acid is excreted unchanged through the kidneys. The dose must be reduced when renal function is impaired; accumulation increases the risk of toxicity, including neurological adverse effects. Significant renal impairment may make treatment inappropriate or require a substantially altered regimen.

Seizures

Seizures are a recognised, dose-related risk, reported particularly with high intravenous doses and when the medicine accumulates in renal impairment. A history of seizures requires careful consideration.

Visual disturbance

Rare visual effects, including altered colour vision, have been reported. New visual symptoms require prompt review and usually discontinuation pending medical advice. Ophthalmic monitoring may be considered when prolonged treatment is unavoidable.

Severe allergy

Facial or throat swelling, wheeze, breathing difficulty or a widespread blistering rash requires emergency care.

Who may not be suitable for treatment?

Tranexamic acid may be contraindicated or require particular caution in people with:

  • active thromboembolic disease or a substantial history or risk of thrombosis;
  • significant kidney impairment;
  • upper urinary tract bleeding or suspected ureteric obstruction;
  • a history of seizures;
  • acquired disturbances of colour vision;
  • disseminated intravascular coagulation unless managed by an experienced clinician; or
  • hypersensitivity to tranexamic acid.

Medication review is essential. Anticoagulants and antiplatelet agents can worsen bleeding, but stopping them may cause stroke, pulmonary embolism, heart attack or coronary-stent thrombosis. They should not be stopped merely because haematuria develops without an individual risk assessment involving the prescribing clinician. Likewise, combining tranexamic acid with pro-thrombotic medicines requires caution.

Where does it fit in the management pathway?

Management is guided by severity. Initial care may include resuscitation, correction of significant anaemia or coagulopathy, a large-bore catheter, manual washout and continuous bladder irrigation. Cystoscopy permits clot evacuation, exclusion of tumour and cautery or laser treatment of bleeding areas.

For persistent or recurrent radiation cystitis, options may include intravesical agents, hyperbaric oxygen therapy, selective arterial embolisation and, rarely, urinary diversion or cystectomy. Hyperbaric oxygen is one of the better-studied treatments because it aims to improve tissue oxygenation and new blood-vessel formation rather than merely suppressing an episode of bleeding.

Tranexamic acid may have a role as a bridge or adjunct in a carefully selected patient. Its value must always be balanced against the danger of thrombosis and urinary tract obstruction.

The take-home message

Tranexamic acid can reduce haematuria in some patients, but evidence specifically for radiation cystitis is weak. It is not a cure and should usually be used only for a short, active bleeding episode under medical supervision. There is no established safe or effective duration for continuous long-term use in radiation cystitis. Kidney function, clotting history, the anatomical source of bleeding and concurrent medication must be reviewed before treatment.

Visible haematuria after radiotherapy always deserves proper investigation, particularly if it is recurrent, contains clots or is accompanied by difficulty passing urine.

This article provides general information and does not replace individual medical advice. Tranexamic acid is a prescription medicine in Australia; its use for radiation cystitis must be individualised by the treating clinician.

References

  1. Goucher G, Saad F, Lukka H, Kapoor A. Canadian Urological Association Best Practice Report: Diagnosis and management of radiation-induced hemorrhagic cystitis. Can Urol Assoc J. 2019;13(2):15–23. doi:10.5489/cuaj.5788
  2. Moharamzadeh P, Ojaghihaghighi S, Amjadi M, Rahmani F, Farjamnia A. Effect of tranexamic acid on gross hematuria: a pilot randomized clinical trial study. Am J Emerg Med. 2017;35(12):1922–1925. doi:10.1016/j.ajem.2017.09.012
  3. Abramowitz D, et al. Clinical management of radiation cystitis: a narrative review. AME Med J. 2021;6:30. Clinical management of radiation cystitis
  4. Choi H, et al. Impact of intravesical administration of tranexamic acid on gross hematuria in the emergency department: a before-and-after study. Am J Emerg Med. 2023;68:118–122. doi:10.1016/j.ajem.2023.03.010
  5. Pfizer Australia. Cyklokapron (tranexamic acid) Australian Product Information. Current product information should be checked through the Therapeutic Goods Administration or the sponsor before prescribing. Australian product information
  6. DailyMed. Tranexamic acid injection—prescribing information. US National Library of Medicine. DailyMed drug labelling
  7. Chauncey JM, Wieters JS. Tranexamic Acid. In: StatPearls. Updated 2025. NCBI Bookshelf

 

Radical Prostatectomy After Radiation Therapy for Prostate Cancer

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When prostate cancer returns after radiotherapy

Radiotherapy, whether external-beam radiation or brachytherapy can provide excellent long-term control of localised prostate cancer. However, a rising prostate-specific antigen (PSA) after treatment may indicate that the cancer has returned.

This does not automatically mean that the cancer is still in the prostate, nor does every PSA rise require immediate treatment. Recurrence may be confined to the prostate, present in lymph nodes or bones, or involve more than one site. Some recurrences also progress slowly enough that surveillance may be appropriate.

When clinically significant cancer is proven to have returned within the irradiated prostate, with no evidence of spread elsewhere, removal of the prostate may still offer a chance of cure. This operation is called a salvage radical prostatectomy.

What is a salvage radical prostatectomy?

A salvage radical prostatectomy removes the entire prostate and seminal vesicles after previous prostate radiotherapy. Depending on the cancer and imaging findings, pelvic lymph nodes may also be removed.

The operation may be performed using robotic-assisted or open surgery. A robotic approach can improve magnification and access, but it does not remove the biological effects of previous radiation. Surgeon and centre experience are therefore more important than the label attached to the surgical technique.

Salvage surgery is technically more difficult than a prostatectomy performed before radiotherapy. Radiation can cause:

  • scarring and fibrosis around the prostate;
  • loss of the normal tissue planes between the prostate, bladder and rectum;
  • reduced tissue blood supply;
  • poorer tissue healing; and
  • pre-existing damage to urinary, erectile or bowel function.

For these reasons, salvage prostatectomy should generally be undertaken in a centre with specific experience in complex prostate cancer surgery and access to multidisciplinary care.

When might salvage surgery be considered?

The aim is to identify a man who has a meaningful risk from his recurrent cancer, but whose disease still appears curable with local treatment. Possible indications include:

  • a rising PSA after radiotherapy, commonly assessed using the Phoenix definition: a PSA rise of at least 2 ng/mL above the lowest PSA reached after treatment;
  • prostate cancer confirmed on biopsy after radiotherapy;
  • imaging suggesting that the recurrence is confined to the prostate or immediate surrounding tissues;
  • no evidence of distant metastatic disease;
  • a life expectancy long enough to benefit from curative treatment, often more than 10 years;
  • good general health and fitness for major surgery;
  • acceptable baseline bladder function; and
  • willingness to accept a higher risk of urinary and sexual side effects than with a primary prostatectomy.

Factors such as the PSA level, PSA doubling time, interval since radiotherapy, biopsy Grade Group, clinical stage and the original cancer characteristics help estimate whether salvage treatment is likely to be worthwhile.

Assessment before considering surgery

A rising PSA is the beginning of the assessment—not the final diagnosis. Investigations commonly include:

Review of the original treatment

The radiation dose and field, use of brachytherapy, previous androgen-deprivation therapy, original biopsy grade and pre-treatment imaging should all be reviewed.

Multiparametric MRI

MRI can help identify the site and extent of a local recurrence, assess the seminal vesicles, bladder neck and rectal interface, and guide biopsy. Interpretation after radiation can be challenging and benefits from specialist radiological expertise.

PSMA PET/CT

PSMA PET/CT is used to look for disease in lymph nodes, bones or other organs. Finding metastatic disease usually changes the treatment plan and may mean that removing the prostate would not provide the expected benefit. Very small-volume disease can still be below the resolution of any scan.

Prostate biopsy

Major guidelines recommend pathological confirmation before potentially morbid local salvage therapy. Biopsy can confirm viable cancer, determine its grade and help distinguish clinically important recurrence from post-radiation change. Both targeted and systematic sampling may be considered.

Urinary-function assessment

Assessment may include symptom scores, urine testing, urinary-flow measurement, residual urine ultrasound and cystoscopy. Urodynamic testing may be helpful when there is significant urgency, leakage, poor flow, retention or uncertainty about bladder function.

Who may not be a good candidate?

Salvage prostatectomy is less likely to be appropriate when:

  • metastatic or extensive nodal disease is present;
  • the cancer is unlikely to be completely removable;
  • life expectancy is limited by age, frailty or other illness;
  • the recurrence is low risk and unlikely to threaten health;
  • severe urinary or bowel damage already exists after radiation; or
  • the anticipated harms of surgery outweigh the probability of cancer control.

These are not absolute rules. Individual circumstances should be reviewed by a multidisciplinary team involving urology, radiation oncology, medical oncology, radiology and pathology.

What are the potential benefits?

For carefully selected men, salvage prostatectomy can:

  • remove the recurrent cancer and provide complete pathological staging;
  • provide durable PSA control without immediately committing the patient to lifelong hormonal therapy; and
  • offer a possibility of cure when disease is truly confined to the prostate.

Published results vary considerably because most evidence comes from retrospective series involving highly selected patients. The European Association of Urology reports five-year biochemical recurrence-free estimates broadly around 41–52% in a large contemporary systematic review, while older selected series have reported ranges of approximately 47–82%. A broader meta-analysis of all local salvage approaches found roughly 50–60% five-year recurrence-free survival, without clear evidence that one approach was oncologically superior. These figures should not be interpreted as a personal prediction.

Cancer control is generally more favourable when the PSA is lower, the recurrent tumour is organ-confined, the cancer grade is lower, the PSA doubling time is longer and there is no nodal or distant disease.

Side effects and complications

Complication rates vary with baseline function, radiation type and dose, disease extent, surgical technique, definitions used in studies and surgeon experience. Results from specialist centres may not apply everywhere.

Urinary incontinence

Loss of urinary control is one of the most important risks. Radiation may already have affected the sphincter, bladder and urethral tissues, and surgery removes the prostate through which the urethra passes.

Leakage may range from mild stress incontinence to severe continuous leakage. Pelvic-floor rehabilitation can help, but some men may later require a male sling or artificial urinary sphincter. Continence outcomes reported in the literature vary widely because studies use different definitions; the risk of significant or persistent leakage is clearly higher than after primary prostatectomy.

Erectile dysfunction

Erectile function is often already impaired by radiotherapy, age, vascular disease or hormonal treatment. Preservation of the erectile nerves may be unsafe or technically impossible because of tumour location and radiation fibrosis. Consequently, erectile dysfunction after salvage prostatectomy is very common and recovery of unassisted erections is uncommon.

Rehabilitation and treatment options include tablets, vacuum devices, penile injections and penile prosthesis surgery. As with any radical prostatectomy, ejaculation and natural fertility are lost because the prostate and seminal vesicles are removed.

Bladder-neck contracture or urethral narrowing

Scar tissue may develop where the bladder is reconnected to the urethra. This can cause a weak stream, straining, incomplete emptying, retention or recurrent infection. Treatment may require endoscopic incision or dilatation, sometimes more than once. Repeated procedures can worsen incontinence.

Urine leak and delayed healing

The new bladder-to-urethra join may heal slowly because irradiated tissues have reduced blood supply. A urinary catheter may need to remain in place longer, and imaging may be required before its removal. Persistent leakage can require drainage or further intervention.

Rectal injury and urinary fistula

The rectum can be densely adherent to the prostate after radiotherapy. Rectal injury is uncommon in expert contemporary practice but occurs more often than during primary prostatectomy and can be serious. It may require repair, temporary bowel diversion or, rarely, more extensive surgery. An abnormal connection between the urinary tract and rectum—a rectourinary fistula—is rare but particularly difficult to treat.

Other surgical risks

Other possible complications include bleeding or transfusion, infection, blood clots, lymphocele after lymph-node dissection, injury to nearby structures, anaesthetic complications, chronic pelvic pain and the need for further procedures.

Cancer may still recur

Even when preoperative imaging suggests local disease, microscopic cancer may already exist outside the prostate. PSA may therefore remain detectable or rise again after surgery. Further treatment—such as hormonal therapy, systemic therapy or selected metastasis-directed treatment—may still be required.

Are there alternatives?

Depending on the cancer, previous treatment, anatomy, urinary function and patient priorities, alternatives may include:

  • active monitoring for a slow or low-risk recurrence;
  • androgen-deprivation therapy, sometimes with additional systemic treatment;
  • salvage brachytherapy or stereotactic re-irradiation;
  • cryotherapy;
  • high-intensity focused ultrasound (HIFU); or
  • focal salvage treatment in carefully selected cases.

No single salvage treatment is best for every patient. Available studies are mostly non-randomised and use differing definitions. A large meta-analysis found broadly similar five-year cancer control among local salvage methods, but severe urinary toxicity was higher after salvage prostatectomy than after modern re-irradiation approaches. Treatment should therefore be selected through shared decision-making rather than on cancer-control figures alone.

The bottom line

Radical prostatectomy after prostate radiotherapy is possible and can be curative, but it is not a routine operation. The best candidate is generally a fit man with biopsy-proven, clinically significant recurrence confined to the prostate, no metastatic disease on appropriate staging, a meaningful life expectancy and a clear understanding of the potential functional consequences.

Accurate staging, confirmation by biopsy, assessment of baseline urinary function and review by an experienced multidisciplinary team are essential. The decision must balance the chance of durable cancer control against the higher risks of urinary incontinence, erectile dysfunction, urinary narrowing, poor healing and rectal complications.

This article provides general information and does not replace individual medical advice. Recommendations should be tailored to the pathology, imaging, previous radiation treatment, general health and preferences of each patient.

References

  1. European Association of Urology. EAU Guidelines on Prostate Cancer: Treatment—management of PSA failure after radiation therapy and salvage radical prostatectomy. Current online edition. https://uroweb.org/guidelines/prostate-cancer/chapter/treatment
  2. Morgan TM, et al. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline. Journal of Urology. 2024. https://www.auanet.org/guidelines-and-quality/guidelines/salvage-therapy-for-prostate-cancer
  3. Valle LF, et al. A systematic review and meta-analysis of local salvage therapies after radiotherapy for prostate cancer (MASTER). European Urology. 2021;80(3):280–292. doi:10.1016/j.eururo.2020.11.010.
  4. Grubmüller B, et al. Salvage radical prostatectomy for radio-recurrent prostate cancer: an updated systematic review of oncological, histopathological and functional outcomes and predictors. European Urology Focus. 2021;7(5):967–978.
  5. Perera M, et al. Morbidity of salvage radical prostatectomy: limited impact of the minimally invasive approach. European Urology Open Science. 2022;39:64–72.
  6. Zumsteg ZS, et al. The natural history and predictors of outcome following biochemical relapse in the dose-escalation era for prostate cancer patients undergoing definitive external beam radiotherapy. European Urology. 2015;67(6):1009–1016.

 

Focal Laser Therapy for Localised Prostate Cancer: What Do We Know?

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Focal therapy is an evolving approach to treating selected prostate cancers. Instead of treating or removing the entire prostate, it aims to destroy the identified cancer while preserving as much surrounding prostate tissue as possible.

One technique under investigation uses laser energy delivered through a fine fibre placed into the prostate. Early clinical reports are encouraging, but focal laser therapy is not suitable for every cancer and long-term evidence remains limited compared with established treatments such as radical prostatectomy and radiotherapy.

This article explains the disease, the principle of focal laser ablation, the early Guy’s Hospital pilot and the questions patients should consider before choosing treatment. It does not recommend a particular product, device or provider.

Understanding localised prostate cancer

Localised prostate cancer appears confined to the prostate on the available investigations. However, cancers vary greatly in their grade, size, position and biological behaviour.

Assessment commonly considers:

  • PSA level and PSA density
  • digital rectal examination findings
  • multiparametric prostate MRI
  • prostate-biopsy grade, often reported using Grade Group
  • number, position and extent of positive biopsy cores
  • whether clinically significant cancer is present in one or several parts of the prostate
  • the patient’s age, health, life expectancy and preferences
  • staging investigations where indicated

Some low-risk cancers may be monitored safely with active surveillance. Other cancers require treatment because their features suggest a meaningful risk of growth or spread.

What is focal therapy?

Focal therapy treats the known area of clinically significant cancer rather than the whole prostate. Depending on the extent and location of disease, treatment may target a small focus, a larger region or one side of the gland.

Energy sources used or investigated for focal therapy include:

  • high-intensity focused ultrasound
  • cryotherapy
  • irreversible electroporation
  • focal laser ablation
  • other thermal or energy-based techniques

These methods are not interchangeable. Each has different equipment, treatment planning, evidence, limitations and regulatory status.

How does focal laser ablation work?

Focal laser ablation delivers laser energy through a thin fibre positioned within the planned treatment area. The energy heats and destroys targeted tissue.

Placement may be performed through the perineum, the area between the scrotum and anus, with MRI and ultrasound information used to guide treatment planning and positioning. Temperature monitoring, cooling systems or other safeguards may be used according to the particular technique.

The intended advantage is to treat the cancer focus while reducing injury to structures involved in urinary continence, erections and bowel function. This is a treatment aim, not a guarantee. Damage to surrounding tissue and functional side effects remain possible.

What did the Guy’s Hospital pilot report?

Guy’s Hospital in London began a pilot involving 30 patients with localised prostate cancer. According to the hospital information reported by the BBC, assessment of the first 10 treated patients found no remaining cancer in the treated area in eight, while two had a small amount of residual cancer.

These figures should be interpreted cautiously:

  • they concern only the first 10 patients of a small pilot
  • they describe early findings in the treated area, not long-term cure
  • cancer may be present elsewhere in the prostate
  • follow-up was not long enough to establish durability, metastasis prevention or survival benefit
  • results from carefully selected research participants may not apply to all patients

The pilot includes ongoing follow-up, including imaging. Larger studies, longer observation and peer-reviewed comparative evidence are needed before firm conclusions can be drawn about long-term cancer control and functional outcomes.

Who might be considered for focal therapy?

Focal therapy may be discussed for carefully selected patients whose clinically significant cancer can be identified and targeted while untreated areas can be monitored reliably.

Selection may take account of:

  • MRI-visible disease
  • biopsy confirmation and cancer grade
  • location, volume and number of cancer foci
  • proximity to the urethra, urinary sphincter, rectum and neurovascular structures
  • prostate size and anatomy
  • previous prostate treatment
  • ability and willingness to undergo close follow-up and repeat biopsy
  • availability of appropriate expertise and governance

Multifocal, poorly defined, extensive or higher-risk cancer may make a focal approach unsuitable. An apparently single MRI lesion does not prove that no important cancer exists elsewhere in the gland.

What assessment is needed beforehand?

Accurate mapping of the cancer is essential. Depending on the patient, assessment may include:

  • review of PSA history
  • high-quality multiparametric MRI
  • targeted and systematic transperineal biopsy
  • expert radiology and pathology review
  • staging imaging when indicated by risk
  • baseline urinary, erectile and bowel function assessment
  • discussion by a multidisciplinary prostate-cancer team

A treatment decision should not be based on MRI alone. Biopsy remains important for confirming the grade and distribution of cancer.

Potential advantages

Possible advantages for appropriately selected patients include:

  • treatment directed at the known cancer rather than the entire prostate
  • usually a shorter procedure and recovery than radical prostatectomy
  • potential for same-day discharge
  • a lower treatment burden for some patients
  • the possibility of preserving urinary and sexual function more often than with whole-gland treatment
  • retention of other treatment options if further cancer is later detected

These are potential advantages, not assured outcomes. Comparisons with surgery or radiotherapy are difficult because patient selection, outcome definitions and follow-up periods differ across studies.

Risks and limitations

Possible complications include:

  • blood in the urine or semen
  • discomfort, bruising or swelling
  • urinary infection
  • difficulty passing urine or temporary catheterisation
  • urinary retention
  • urethral narrowing
  • urinary urgency or leakage
  • erectile or ejaculatory changes
  • injury to tissue surrounding the prostate
  • residual cancer within the treated area
  • clinically significant cancer elsewhere in the prostate
  • need for repeat focal treatment or conversion to surgery or radiotherapy

Rare but serious complications may occur. The specific risk profile depends on the technology, treatment location, operator experience and individual anatomy.

Focal therapy does not remove the need for surveillance

Unlike radical prostatectomy, focal therapy leaves prostate tissue behind. PSA therefore remains detectable and cannot be interpreted in the same way as after complete prostate removal.

Follow-up may include:

  • regular PSA testing
  • clinical review
  • repeat MRI
  • targeted and systematic repeat biopsy
  • assessment of urinary and sexual function

Imaging alone may not exclude residual or recurrent cancer. Patients need to be willing to undergo structured, long-term surveillance and possible further biopsy or treatment.

How does it compare with established options?

Active surveillance

Active surveillance avoids or delays treatment in suitable patients with lower-risk disease. It involves scheduled PSA tests, MRI, examination and repeat biopsy. It avoids immediate treatment side effects but carries the burden of monitoring and the possibility that treatment will later be required.

Radical prostatectomy

Surgery removes the prostate and seminal vesicles and provides complete pathological assessment of the removed gland. It has extensive long-term evidence for selected patients but may cause urinary incontinence, erectile dysfunction, loss of ejaculation and other surgical complications.

Radiotherapy

External-beam radiotherapy and brachytherapy are established treatments for localised prostate cancer. Risks may include urinary, bowel and sexual effects, which can develop during treatment or later. Some patients also require androgen-deprivation therapy.

Focal therapy

Focal therapy attempts to balance cancer control with preservation of function. Its principal uncertainties are the selection of suitable patients, untreated cancer elsewhere in the prostate, definitions of treatment success and the lack of mature comparative and long-term cancer-control data.

What happens if cancer remains or returns?

Further management depends on the location and risk of the cancer, previous treatment and patient preference. Options may include:

  • continued surveillance in selected circumstances
  • repeat focal treatment
  • radical prostatectomy
  • radiotherapy
  • another appropriate cancer treatment

Salvage treatment after focal therapy may be technically more complex and can have different side-effect rates from primary treatment. Patients should discuss the available rescue options before choosing focal therapy, not only after treatment failure.

Australian regulatory status and access

Regulatory status, approved indications, availability, reimbursement and participation in clinical trials can change. A device being used in research overseas does not automatically mean that the same system is approved, routinely available or publicly funded in Australia.

Patients considering a particular technology should ask:

  • Is the exact device included in the Australian Register of Therapeutic Goods for the proposed use?
  • Is treatment being offered as standard care, through a clinical trial or under another access pathway?
  • What evidence supports this technique for my particular cancer?
  • What costs and follow-up procedures are involved?
  • Who will manage surveillance and any residual or recurrent cancer?

Current regulatory information should be confirmed directly through the Therapeutic Goods Administration and the treating institution. This article does not make a claim that any named focal-laser system is TGA approved.

Questions to ask your prostate-cancer team

  • What is my Grade Group and clinical risk category?
  • Is the cancer confined to one clearly targetable area?
  • How confident are we that significant cancer is not present elsewhere?
  • Is active surveillance a safe option for me?
  • What are the established alternatives and their long-term outcomes?
  • What evidence is available for this focal technique?
  • How will success be measured?
  • Will I need another biopsy?
  • What are the urinary, sexual and bowel risks?
  • What happens if the cancer is not completely treated or later recurs?
  • Is this standard treatment or part of a research study?

The bottom line

The early Guy’s Hospital experience adds to growing interest in focal laser treatment for localised prostate cancer. The reported initial findings are encouraging, but 10 early cases cannot establish long-term cure, comparative effectiveness or safety.

Focal therapy may be reasonable to discuss for carefully selected patients who understand the uncertainties and accept close surveillance. It should be considered alongside active surveillance, surgery and radiotherapy through shared decision-making with an experienced multidisciplinary team.

This article provides general disease education. It does not recommend or promote a particular therapeutic device, treatment system, clinician or health service and does not replace individual medical advice. Regulatory status and clinical evidence should be checked at the time treatment is considered.

References and further reading

Publication note

This is an original educational article, not a republication of the BBC report.

Focal Therapy for Prostate Cancer: Targeting the Cancer While Preserving the Prostate

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Established management of localised prostate cancer includes active surveillance for suitable low-risk disease and whole gland treatment with surgery or radiotherapy when treatment is indicated. ProFocal® is a newer focal approach that uses laser energy to destroy a selected cancerous area while leaving much of the surrounding prostate untreated.

This approach is known as focal laser therapy or focal laser ablation. Its intended aim is to control the treated cancer focus while reducing urinary and sexual side effects. Whether it provides cancer control equivalent to established whole-gland treatments over the long term has not been demonstrated.

Early Australian research is encouraging. However, ProFocal remains an investigational treatment, and important questions about its long-term cancer control have not yet been answered.

What is ProFocal therapy?

ProFocal is an Australian-developed focal therapy system designed to treat a carefully selected area of prostate cancer.

A fine laser applicator is inserted through the skin between the scrotum and anus, the perineum, and guided into the prostate using imaging. Laser energy heats the targeted tissue to a temperature that causes cancer-cell death.

The system incorporates cooling and real-time temperature monitoring. This is intended to make the area of ablation more predictable and to limit unintended heat damage to nearby structures such as the:

  • Urinary sphincter
  • Urethra
  • Bladder neck
  • Rectum
  • Neurovascular bundles involved in erections

Unlike radical prostatectomy, ProFocal does not remove the prostate. Unlike conventional radiotherapy, it does not expose the whole prostate to radiation.

Is ProFocal approved by the TGA?

This requires careful clarification.

As at September 2026, the manufacturer states that ProFocal is not included in the Australian Register of Therapeutic Goods, ARTG. It therefore does not have general TGA market authorisation for routine supply and use in Australia.

This is different from saying that the treatment has received unrestricted “TGA approval.”

ProFocal may be accessible in Australia through a clinical trial or a specific TGA pathway for an unapproved therapeutic good, such as the Authorised Prescriber Scheme or Special Access Scheme. These pathways permit access in defined circumstances; they are not equivalent to ARTG inclusion or routine TGA market authorisation. The applicable approval, governance and consent arrangements should be confirmed for the individual patient.

Authorised Prescriber access does not mean that the device has been entered on the ARTG or endorsed as routine standard treatment. Regulatory status, trial availability and funding arrangements should always be confirmed directly before treatment.

Medicare, private insurance and professional oversight in Australia

The Medicare Benefits Schedule (MBS) lists professional medical services subsidised by the Australian Government. As at September 2026, no specific MBS item for “ProFocal” or focal laser ablation of prostate cancer was identified in the current public MBS material reviewed for this article. This should not be interpreted as a definitive ruling on every component of an episode of care: consultations, anaesthesia, imaging, pathology or hospital services may each have different billing arrangements.

An MBS rebate for an associated service would not establish that ProFocal itself is TGA-approved, guideline-endorsed or proven effective. Conversely, lawful access through a TGA pathway does not guarantee Medicare or private-insurance funding. The Department of Health and Aged Care’s Medical Services Advisory Committee (MSAC) is the independent body that advises government on whether public funding of medical services and technologies is supported by evidence of safety, clinical effectiveness and cost-effectiveness.

The Australian Medical Association (AMA) is a professional representative body, not the regulator of therapeutic goods and not the agency that creates Medicare items. No AMA clinical guideline specifically recommending ProFocal was identified for this review. It would therefore be inappropriate to imply AMA endorsement. Relevant professional duties instead arise from the Medical Board of Australia’s code of conduct: patients should receive understandable information about the proposed treatment, reasonable alternatives, material risks, uncertainties, costs and any practitioner conflicts of interest so that consent is genuinely informed.

Who may be considered for ProFocal therapy?

ProFocal is principally being studied in men with localised, non-metastatic and MRI-visible prostate cancer.

In the first prospective phase II ProFocal study, eligible men had:

  • Prostate cancer confined to the prostate
  • An MRI-visible cancer target
  • ISUP Grade Group 2 or 3 disease
  • A PSA of 15 ng/mL or lower
  • A clinical stage of T2c or lower
  • Biopsy findings corresponding with the abnormality seen on MRI

Outside a clinical trial, suitability would need to be assessed individually by a multidisciplinary prostate cancer team.

A potential candidate generally requires a cancer that can be clearly identified, biopsied and safely surrounded by an adequate treatment margin. Detailed assessment usually includes:

  • Multiparametric prostate MRI
  • Targeted and systematic transperineal biopsies
  • PSA and PSA-density assessment
  • Clinical staging
  • Consideration of PSMA PET/CT in selected men
  • Review of the MRI and pathology at a multidisciplinary meeting

When may ProFocal be unsuitable?

ProFocal would generally not be considered appropriate when there is:

  • Metastatic prostate cancer
  • High-risk or locally advanced disease requiring comprehensive treatment
  • Cancer outside the prostate
  • Extensive cancer involving several areas of the gland
  • Cancer that cannot be reliably identified on MRI
  • A tumour position where an adequate and safe treatment margin cannot be achieved
  • Significant uncertainty about the true extent or grade of the cancer
  • An inability or unwillingness to undergo ongoing MRI scans and repeat biopsies
  • A medical condition that makes anaesthesia or the procedure unacceptably risky

Men with low-risk Grade Group 1 prostate cancer may be better managed with active surveillance, avoiding treatment and its potential complications altogether.

Focal therapy should not be regarded as an easier substitute for appropriate surgery or radiotherapy in men with aggressive, high-volume or advanced prostate cancer.

How is ProFocal treatment performed?

ProFocal is usually performed as a day procedure under general anaesthesia.

Treatment planning

The cancer identified on MRI and biopsy is mapped carefully. The treatment plan includes the visible tumour and an additional safety margin intended to treat microscopic cancer immediately around it.

Placement of the laser applicator

With the patient under anaesthesia, a transrectal ultrasound probe is used to visualise the prostate. A fine laser applicator is inserted through the perineum and positioned within the selected treatment area.

The route is similar to that used for a transperineal prostate biopsy.

Laser ablation

Controlled laser energy heats and destroys the targeted prostate tissue. Temperature monitoring helps the surgeon assess treatment delivery and protect surrounding structures. More than one applicator position may be needed to cover the planned treatment zone.

The published phase II study reported a median treatment time of approximately 60 minutes, although the complete anaesthetic and theatre procedure may take longer.

Recovery

A urinary catheter may be required temporarily because prostate swelling can make urination difficult. Many patients can return home on the day of treatment or after a short admission, depending on their recovery and ability to pass urine.

What are the potential advantages?

The proposed advantages of ProFocal include:

  • Treatment directed at the known cancer rather than the whole prostate
  • No abdominal incision
  • A transperineal, minimally invasive approach
  • Short hospital stay
  • Faster initial recovery than major surgery
  • No ionising radiation
  • Preservation of untreated prostate tissue
  • A potentially lower risk of persistent urinary incontinence
  • A potentially lower risk of erectile dysfunction than whole gland treatment
  • The possibility of further focal or whole-gland treatment if cancer remains or returns

These are potential benefits and should not be interpreted as guarantees.

How does it compare with established alternatives?

There is no mature randomised evidence showing that ProFocal gives the same long-term protection from metastasis or prostate-cancer death as radical prostatectomy or radiotherapy. A balanced consultation should therefore compare all reasonable options:

  • Active surveillance: avoids or delays treatment side effects and is preferred for many men with low-risk disease, but requires PSA testing, MRI and repeat biopsy, with treatment if the cancer progresses.
  • Radical prostatectomy: removes the prostate and provides complete surgical pathology. It has long-term cancer-control data, but carries risks including urinary incontinence, erectile dysfunction, loss of ejaculation and surgical complications.
  • Radiotherapy: has established long-term cancer-control data and avoids surgery, but may cause urinary, bowel and sexual adverse effects; androgen-deprivation therapy may be advised for some risk groups.
  • ProFocal/focal laser ablation: may offer quicker recovery and less short-term urinary or sexual morbidity for carefully selected men, but leaves untreated prostate tissue, requires MRI and repeat-biopsy surveillance, and has uncertain long-term comparative cancer-control outcomes.

The most appropriate option depends on cancer grade, volume and location; PSA and stage; age and general health; baseline urinary and sexual function; personal priorities; and willingness to accept surveillance or treatment uncertainty. A multidisciplinary opinion and, where useful, separate discussions with a urologist and radiation oncologist can reduce treatment-selection bias.

What did the early ProFocal study find?

The first published phase II trial included 100 men with localised, MRI-visible Grade Group 2 or 3 prostate cancer.

At the three-month biopsy:

  • 84% had no clinically significant Grade Group 2 or higher cancer within the treated area
  • Approximately 16% therefore had residual clinically significant cancer within the treatment zone
  • Erectile dysfunction was reported in 12%
  • The average sexual-function scores decreased by approximately 15%
  • Urinary-domain scores decreased by approximately 4.5%
  • No significant deterioration was reported in the other measured functional outcomes

These results are promising, but they represent very early follow-up. The study had no surgery, radiotherapy or active surveillance control group. It therefore cannot establish whether ProFocal provides equivalent long-term protection against recurrence, metastasis or death from prostate cancer.

Possible side effects and complications

Short-term effects may include:

  • Bruising or discomfort in the perineum
  • Blood in the urine
  • Blood in the semen
  • Burning or discomfort when urinating
  • Urinary frequency or urgency
  • Temporary difficulty passing urine
  • Temporary catheterisation
  • Urinary tract infection
  • Pelvic or rectal discomfort
  • Fatigue following anaesthesia

Potential longer-term or less common problems include:

  • New or worsening erectile dysfunction
  • Reduced ejaculatory volume
  • Retrograde ejaculation
  • Urinary incontinence
  • Urethral or bladder-neck scarring
  • Persistent urinary symptoms
  • Damage to tissue outside the intended treatment zone
  • Infection or abscess
  • A fistula involving the urinary tract and rectum, expected to be rare
  • Incomplete cancer treatment
  • Cancer developing or becoming apparent elsewhere in the untreated prostate
  • A requirement for repeat focal therapy, radiotherapy or radical prostatectomy

The risk of sexual or urinary dysfunction depends partly on the size and location of the tumour. A lesion near the neurovascular bundles, urethra, urinary sphincter or bladder neck may be more difficult to treat without affecting function.

The untreated prostate remains important

Prostate cancer is frequently multifocal, meaning that separate areas of cancer may exist within the same prostate. MRI is very useful but cannot detect every small or biologically significant tumour.

ProFocal treats the selected target, not every prostate cell.

This creates two possible patterns of treatment failure:

  1. In-field disease: cancer remains or returns inside the treated area.
  2. Out-of-field disease: cancer is subsequently found elsewhere in the untreated prostate.

A successful early scan does not prove that all clinically significant cancer has been eliminated.

Follow-up after ProFocal therapy

Follow-up is more intensive than simply checking the PSA.

Because the prostate remains in place, PSA will not normally fall to an undetectable level. There is also no universally accepted PSA threshold that defines successful focal treatment or recurrence.

Follow-up may include:

  • Regular PSA testing
  • Clinical review and symptom assessment
  • Multiparametric MRI
  • Quality-of-life and erectile function assessment
  • Repeat targeted biopsy of the treated area
  • Systematic biopsy of the untreated prostate
  • Additional imaging when recurrence is suspected

The Prostate Cancer Foundation of Australia cautions that PSA testing alone is not sufficient to exclude recurrent cancer after focal therapy. Patients must be willing to undergo long-term imaging and, when recommended, further prostate biopsies.

Can treatment be repeated?

Repeat focal treatment may be possible when residual or recurrent cancer remains localised and clearly targetable.

Depending on the findings, subsequent options may include:

  • Repeat focal ablation
  • Radical prostatectomy
  • External-beam radiotherapy
  • Another focal therapy technique
  • Active surveillance for selected low-volume disease
  • Systemic treatment if the cancer has spread

Salvage surgery or radiotherapy may still be possible after focal therapy, but treatment can sometimes be technically more complex because of scarring and tissue changes. The likely salvage options should therefore be discussed before proceeding with ProFocal.

Important limitations

Patients considering ProFocal should understand that:

  • ProFocal is not currently included on the Australian ARTG
  • It is not established as routine standard-of-care treatment
  • Published ProFocal evidence currently comes from a small number of men
  • The pivotal study was single-arm and had very short follow-up
  • Long-term rates of metastasis-free, cancer-specific and overall survival are unknown
  • There are no mature randomised comparisons with prostatectomy, radiotherapy or modern active surveillance
  • Approximately 16% of men in the initial study had clinically significant cancer remaining in the treated area at three months
  • Cancer may be missed elsewhere in the prostate
  • Repeat MRI scans and biopsies are required
  • Further cancer treatment may be needed
  • Access may be limited to trials or special regulatory pathways
  • Medicare or private health insurance may not cover treatment or follow-up costs

What do Australian and international guidance sources say?

The Prostate Cancer Foundation of Australia (PCFA) describes focal therapies as emerging and experimental. It notes that focal treatment may reduce side effects but that the prostate remains in place, PSA monitoring is less straightforward, and ongoing MRI and biopsy are required.

Australian evidence-based resources regard active surveillance, radical prostatectomy and radiotherapy as established pathways for appropriately selected localised disease. ProFocal has not yet acquired the same evidence base or standard-of-care status. The absence of a treatment-specific recommendation should not be reframed as support.

The European Association of Urology (EAU) states that focal therapy has favourable functional outcomes but that definitive evidence of long-term oncological benefit remains unavailable. Its guideline recommends focal HIFU or cryotherapy only within a prospective registry and other ablative methods—including focal laser therapy—only within a well-designed prospective clinical trial.

The American Urological Association and American Society for Radiation Oncology advise clinicians that comparative evidence for focal ablation is lacking and that patients must be informed that further treatment may be required. Focal or whole-gland ablation should not be offered for high-risk prostate cancer outside a clinical trial.

The UK National Institute for Health and Care Excellence (NICE) guidance for focal HIFU and focal cryoablation—not ProFocal specifically—also emphasises special governance, consent, audit/research arrangements and uncertainty about long-term cancer control. This is relevant context for focal therapy but must not be represented as device-specific approval of ProFocal.

The Prostate Cancer Foundation of Australia similarly describes focal therapies as experimental and emphasises the need for continuing MRI, biopsies and careful long-term monitoring.

The bottom line

ProFocal is an Australian-developed investigational technology that may eventually provide selected men with an additional option between surveillance and whole-gland treatment.

Its early results suggest that precisely delivered cooled laser therapy can destroy an MRI-visible prostate cancer target with relatively limited short-term urinary morbidity. However, early cancer clearance is not the same as proven long-term cancer control.

At present, ProFocal should be considered an investigational focal therapy. Consistent with current guidance for focal laser ablation, its most defensible use is within a well-designed prospective clinical trial with ethics and regulatory oversight, multidisciplinary assessment, explicit informed consent, independent outcome reporting and mandatory long-term follow-up.

The decision should be made only after comparing ProFocal with all appropriate alternatives, including active surveillance, radical prostatectomy and radiotherapy.

This article provides general information and does not replace individual medical advice. Regulatory status and treatment availability can change and should be confirmed at the time of consultation.

References and further reading

Protecting the Rectum During Prostate Radiotherapy: A Patient Guide

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Radiotherapy is an established treatment for many men with prostate cancer. Modern planning and image-guidance techniques can direct radiation accurately, but the prostate lies immediately in front of the rectum. Because the two organs are so close, part of the rectal wall may receive radiation during treatment.

Radiation teams use several methods to limit exposure to surrounding healthy tissue. For selected patients, one option is to place a temporary biodegradable material between the prostate and rectum before radiotherapy planning.

This article explains why bowel effects occur, how rectal spacing works, its possible benefits and limitations, and the questions patients should discuss with their treating team. It does not recommend a particular product, device or brand.

Why can prostate radiotherapy affect the bowel?

The front wall of the rectum normally sits very close to the back of the prostate. Radiation directed at the prostate may therefore also reach a small amount of nearby rectal tissue.

Possible bowel effects during or after radiotherapy include:

  • increased bowel frequency
  • urgency
  • loose stools or diarrhoea
  • mucus discharge
  • rectal discomfort
  • bleeding
  • inflammation known as radiation proctitis

Many bowel symptoms are mild and settle after treatment, but some develop later or persist. Risk varies with the radiation technique, dose, fractionation schedule, individual anatomy, bowel health, medicines and previous pelvic treatment.

Rectal bleeding after radiotherapy should not automatically be attributed to radiation. Other causes, including haemorrhoids, polyps, inflammatory bowel disease and bowel cancer, may require investigation.

How is the rectum protected?

Protection begins with careful radiotherapy planning rather than with a spacer alone. Strategies may include:

  • intensity-modulated or volumetric-modulated radiotherapy
  • image guidance before and during treatment
  • accurate bladder and bowel preparation
  • management of rectal gas or stool
  • individualised dose constraints
  • limiting movement of the prostate
  • selecting an appropriate radiation schedule
  • a temporary rectal spacer in selected patients

A spacer is therefore an additional planning tool, not a substitute for high-quality radiation oncology.

What is a rectal spacer?

A rectal spacer is a temporary biodegradable material placed into the tissue plane between the prostate and the anterior rectal wall. Increasing this distance may reduce the radiation dose received by the rectum.

Materials used in currently available spacer systems include:

  • polyethylene-glycol hydrogel
  • stabilised hyaluronic-acid gel

These materials have different handling and imaging characteristics. They should not be assumed to have identical evidence, contraindications or safety profiles.

A spacer does not treat prostate cancer. Its role is to alter the anatomy temporarily while radiation treats the cancer.

Do all men having prostate radiotherapy need a spacer?

No. Many patients can receive carefully planned radiotherapy without one.

Potential benefit depends on factors such as:

  • the natural distance between the prostate and rectum
  • prostate size and shape
  • tumour position and extent
  • radiation dose and treatment schedule
  • the ability to meet rectal dose constraints without a spacer
  • previous prostate or pelvic procedures
  • bowel disease
  • bleeding risk and relevant medicines
  • whether pelvic lymph nodes are also being treated
  • local expertise and access

For some patients, the predicted reduction in rectal dose may be clinically meaningful. For others, the benefit may be small, uncertain or outweighed by the insertion risk.

The decision is usually made with the radiation oncologist. A urologist or another trained proceduralist may also be involved.

What does the evidence show?

Clinical studies of biodegradable rectal spacers generally show that increasing the distance between the prostate and rectum can reduce the radiation dose delivered to parts of the rectal wall.

A multicentre randomised trial involving 201 men receiving hypofractionated prostate radiotherapy evaluated a hyaluronic-acid spacer. The study reported improved rectal dosimetry and fewer acute grade 2 or worse gastrointestinal adverse events in the spacer group than in the control group.

These findings are relevant but require context:

  • dosimetric improvement does not guarantee that an individual patient will avoid bowel symptoms
  • trial participants and treatment protocols may differ from patients treated in routine practice
  • evidence for short-term bowel outcomes is stronger than evidence for some long-term outcomes
  • results for one spacer material or insertion technique should not automatically be applied to another
  • operator experience and correct placement affect both benefit and risk

Patients should ask how the published evidence applies to their planned radiotherapy technique and personal anatomy.

How is a spacer inserted?

The procedure is generally performed before radiotherapy planning.

Under ultrasound guidance, a needle is passed through the perineum—the skin between the scrotum and anus—into the potential space between the prostate and rectum. The tissue plane is checked carefully, and the spacer material is then introduced while its position is monitored.

Depending on the patient and treating centre, the procedure may use:

  • local anaesthesia
  • sedation
  • general anaesthesia

Fiducial markers used to help target radiotherapy may sometimes be inserted during the same procedure.

The exact preparation, antibiotic policy, management of anticoagulants and post-procedure care vary. Patients should follow the instructions given by their treating team.

Why does correct placement matter?

The spacer needs to create suitable separation along the part of the rectum closest to the planned radiation target. Too little separation, marked asymmetry or injection into the wrong tissue plane may reduce the expected dosimetric benefit.

Incorrect placement may also injure the rectal wall, prostate, urethra, bladder or nearby blood vessels. Training, real-time imaging, careful patient selection and recognition of abnormal anatomy are therefore important.

Some hyaluronic-acid materials can be broken down with an enzyme if significant malposition is recognised. This does not make incorrect placement harmless or remove the need for prevention, prompt assessment and appropriate management.

Who may be unsuitable?

Suitability depends on the particular device instructions, the patient’s anatomy and the clinical situation. Reasons to avoid or reconsider insertion may include:

  • infection or inflammation near the proposed injection site
  • inability to identify a safe tissue plane
  • tumour extending into the space behind the prostate
  • extensive scarring from previous surgery or treatment
  • significant rectal or anorectal disease
  • uncorrected bleeding disorder
  • anticoagulant or antiplatelet therapy that cannot be managed safely
  • allergy or hypersensitivity relevant to the proposed material
  • significant immunosuppression
  • a situation in which the expected dosimetric benefit is minimal

The approved Australian instructions for use for the exact device should be checked by the treating clinician.

Anticoagulant and antiplatelet medicines must not be stopped without advice from the clinician who manages them. Interrupting these medicines can cause stroke, heart attack, thrombosis or other serious harm.

Possible short-term effects

Temporary effects may include:

  • perineal discomfort or bruising
  • minor bleeding
  • a sensation of rectal fullness
  • discomfort when opening the bowels
  • urinary frequency or burning
  • a weaker urinary stream
  • constipation

The pattern and duration vary. New, severe or worsening symptoms require clinical review.

Uncommon but important complications

Spacer insertion is invasive and can cause serious complications, even when performed carefully.

Reported or plausible complications include:

  • infection, prostatitis or pelvic abscess
  • bleeding or haematoma
  • urinary retention
  • significant rectal or pelvic pain
  • spacer malposition or migration
  • injection into the rectal wall, prostate or another unintended site
  • injury to the urethra, bladder, rectum or blood vessel
  • rectal ulceration or tissue necrosis
  • embolic or vascular complications
  • fistula formation
  • need for further treatment, hospital admission or surgery

Severe pain, fever, difficulty passing urine, heavy bleeding, worsening bowel symptoms or feeling systemically unwell after the procedure should be assessed promptly.

What happens to the spacer?

Biodegradable spacers are intended to remain during the radiotherapy period and then gradually break down and be absorbed.

The expected duration and degradation process depend on the material. A second operation is not normally required solely to remove an appropriately placed biodegradable spacer.

Different spacer materials

The choice should not be reduced to a promotional comparison between brand names. Relevant clinical differences may include:

Consideration Hyaluronic-acid gel Polyethylene-glycol hydrogel
Primary purpose Temporary prostate–rectum separation Temporary prostate–rectum separation
Typical placement Transperineal, image-guided Transperineal, image-guided
Biodegradable Yes Yes
Handling Deposited and shaped during injection Forms a hydrogel after delivery
Imaging Visibility depends on material and imaging method Some formulations are designed for greater CT visibility
Evidence Randomised and observational studies are available Randomised, prospective and observational studies are available
Key limitation Insertion-related risk and dependence on correct placement Insertion-related risk and dependence on correct placement

This table is descriptive, not a claim that one material is safer or more effective. Head-to-head observational comparisons may be affected by patient selection, injected volume, operator technique, learning curve and treatment planning. They cannot by themselves establish universal superiority.

What about previous surgery or salvage radiotherapy?

Previous prostate procedures, pelvic surgery, focal therapy, radiotherapy or inflammation may alter the tissue plane behind the prostate. This can make placement more difficult or unsuitable.

The evidence for spacers in salvage or re-irradiation settings is less established than for primary prostate radiotherapy. These cases require individual assessment in an experienced multidisciplinary setting.

Questions to ask before deciding

  • What bowel risks are associated with my proposed radiotherapy plan?
  • Can the required rectal dose limits be met without a spacer?
  • What additional benefit is expected in my anatomy?
  • What spacer material is proposed, and is the exact device included in the ARTG for this intended use?
  • What evidence supports it for my radiation schedule?
  • Who will perform the procedure, and what is their experience?
  • What are the recognised contraindications and complications?
  • How will my anticoagulant or antiplatelet medicines be managed?
  • What symptoms after insertion require urgent review?
  • What are the alternatives if I choose not to have a spacer?
  • Are there additional costs or gaps?

Australian regulatory considerations

The Australian Register of Therapeutic Goods (ARTG) is the public database of therapeutic goods that may be legally supplied in Australia, unless an exemption or another authorised access pathway applies. An ARTG entry records the particular sponsor and intended purpose; it is not a general recommendation that the product is best for an individual patient.

Device inclusion, instructions for use, contraindications, availability and reimbursement can change. The treating team should confirm the current ARTG entry and approved instructions for the exact device proposed.

The bottom line

The rectum lies close to the prostate and may receive some radiation during prostate-cancer treatment. Modern planning and image guidance are the foundation of rectal protection.

A biodegradable rectal spacer can create temporary separation and may reduce rectal radiation exposure in selected patients. It does not treat the cancer, cannot guarantee freedom from bowel effects and introduces procedural risks of its own.

The decision should be individualised according to anatomy, the proposed radiation plan, expected dosimetric benefit, medical history, bleeding risk and local expertise. It should be made before radiotherapy planning through an informed discussion with the treating radiation oncology team.

This article provides general disease education and does not replace individual medical advice. It does not promote or recommend a particular therapeutic device, spacer material, brand, clinician or health service.

References and further reading

 

Advanced and Metastatic Prostate Cancer: Modern Treatment and New Hope

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A diagnosis of advanced or metastatic prostate cancer can be frightening. However, the treatment landscape has changed dramatically over the past decade.

Where doctors once relied mainly on testosterone-lowering treatment, we now have combinations of androgen deprivation therapy (ADT), modern androgen-receptor medicines, chemotherapy, targeted treatments, radioligand therapy and, for selected cancers, immunotherapy.

Importantly, these treatments are increasingly being used earlier and in combination, rather than waiting for one treatment to fail before introducing the next.

The aim is not simply to lower the PSA. It is to control the cancer for as long as possible while maintaining quality of life.

What does “advanced” prostate cancer mean?

Advanced prostate cancer is not one single condition.

Locally advanced prostate cancer

The cancer has grown beyond the prostate or into nearby structures but has not necessarily spread to distant organs.

Metastatic hormone-sensitive prostate cancer

The cancer has spread elsewhere in the body, commonly to:

  • lymph nodes
  • bones
  • lungs
  • liver or other organs

but remains sensitive to testosterone suppression.

This is often abbreviated to mHSPC or metastatic hormone-sensitive prostate cancer.

Metastatic castration-resistant prostate cancer

Over time, prostate cancer cells may learn to grow despite very low testosterone levels.

This is called metastatic castration-resistant prostate cancer (mCRPC).

“Castration resistant” does not mean that there are no further treatments available. Quite the opposite. We now have several effective treatment classes that can be used at this stage.

1. Androgen Deprivation Therapy: The Foundation of Treatment

Prostate cancer cells are usually heavily dependent on male hormones, particularly testosterone.

Androgen deprivation therapy (ADT) reduces testosterone to very low levels.

This can be achieved with regular injections or implants using GnRH/LHRH agonists or antagonists. Surgical removal of the testosterone-producing portion of the testes, called an orchidectomy, remains effective but is now used less frequently.

ADT remains the backbone of treatment for metastatic prostate cancer.

However, an important change in modern prostate cancer management is that ADT alone is usually no longer considered adequate initial treatment for a fit man presenting with metastatic hormone-sensitive disease.

Current EAU recommendations favour combining ADT with another effective systemic treatment whenever the patient is sufficiently fit.

2. Double Therapy

One approach combines ADT with a modern androgen-receptor pathway inhibitor (ARPI).

Examples include:

Abiraterone + prednisone

Abiraterone blocks androgen production not only from the testes but also from the adrenal glands and within the cancer itself.

Potential side effects include:

  • high blood pressure
  • low potassium
  • fluid retention
  • abnormal liver function
  • cardiac problems in susceptible patients
  • steroid-related effects

Enzalutamide

This blocks signalling through the androgen receptor.

Possible side effects include fatigue, hypertension, falls, cognitive effects and, rarely, seizures.

Apalutamide

Another potent androgen-receptor inhibitor. Side effects may include fatigue, rash, hypertension, falls and thyroid abnormalities.

Darolutamide

Darolutamide also inhibits androgen-receptor signalling and has relatively limited penetration into the central nervous system, which may be advantageous for some patients.

Current EAU guidance strongly supports treatment intensification rather than ADT alone in suitable patients with metastatic hormone-sensitive disease.

3. Triple Therapy: Three Treatments From the Starting Line

One of the biggest developments in metastatic prostate cancer has been triplet therapy.

Instead of:

ADT alone

or:

ADT + one additional treatment

selected patients may receive:

ADT + chemotherapy + an androgen-receptor pathway inhibitor

Two landmark trials helped establish this approach.

ARASENS

The phase III ARASENS trial investigated:

ADT + docetaxel + darolutamide

compared with:

ADT + docetaxel + placebo

The addition of darolutamide reduced the risk of death by approximately 32.5%, with a hazard ratio for death of 0.68.

Four-year overall survival was approximately 62.7% with triplet therapy compared with 50.4% in the control group.

PEACE-1

The PEACE-1 trial investigated the addition of abiraterone to standard treatment in men with newly diagnosed metastatic prostate cancer.

Among patients receiving ADT and docetaxel, adding abiraterone improved both radiographic progression-free survival and overall survival.

These studies have fundamentally changed how we approach a fit patient presenting with metastatic prostate cancer.

Who may benefit from triple therapy?

Triplet therapy is particularly considered in men who:

  • present initially with metastatic disease
  • have a significant metastatic burden
  • are medically fit enough to receive chemotherapy
  • have an expected lifespan sufficient to benefit from treatment intensification.

Treatment nevertheless needs to be individualised.

The EAU now recommends that when docetaxel is used for first-line metastatic hormone-sensitive disease, it should generally be given as part of combination treatment with ADT plus abiraterone or darolutamide in patients fit enough for chemotherapy.

One important scientific caveat remains: trials clearly demonstrated that triplet treatment is superior to ADT + docetaxel, but direct randomised evidence comparing triplet therapy against ADT + a modern ARPI without chemotherapy remains limited.

4. Chemotherapy

Docetaxel

Docetaxel remains an important chemotherapy for advanced prostate cancer.

It damages rapidly dividing cancer cells and is commonly given intravenously every three weeks for a defined number of cycles when used in hormone-sensitive metastatic disease.

Potential side effects include:

  • fatigue
  • temporary hair loss
  • lowered white blood cell count
  • infection
  • febrile neutropenia
  • anaemia
  • altered taste
  • nail changes
  • peripheral neuropathy
  • fluid retention.

Modern supportive treatment has made chemotherapy considerably more manageable than many patients expect.

Cabazitaxel

Cabazitaxel is generally used later, particularly when metastatic castration-resistant cancer has progressed following docetaxel and androgen-receptor pathway treatment.

Current ASCO recommendations include cabazitaxel as an important later-line treatment following appropriate prior ARPI and docetaxel therapy.

5. Should ADT Ever Be Intermittent?

This is an important question because ADT has significant long-term effects.

With intermittent ADT, treatment is stopped after a good PSA response and restarted when the PSA or cancer activity rises again.

The attraction is obvious: periods away from treatment may allow testosterone recovery and improvements in:

  • sexual function
  • hot flushes
  • energy
  • mood
  • muscle strength
  • metabolic health.

However, metastatic disease is different from some non-metastatic situations.

The large SWOG 9346 study could not establish that intermittent treatment was non-inferior to continuous ADT in metastatic disease. Consequently, a small survival disadvantage from intermittent therapy cannot be excluded.

The 2026 EAU guideline therefore notes that intermittent ADT has largely been superseded by continuous ADT-based combination therapy for metastatic disease.

For most men with metastatic prostate cancer, therefore, continuous hormonal suppression remains the standard.

Intermittent treatment may occasionally be considered in carefully selected circumstances after detailed discussion of the potential quality-of-life benefits and oncological uncertainty.

6. What Happens When the Cancer Becomes Castration Resistant?

A rising PSA despite very low testosterone does not automatically mean treatment has “stopped working.”

Rather, it tells us that the biology of the cancer has changed.

Importantly, ADT is usually continued even after castration resistance develops.

The next treatment depends heavily upon what the patient has already received.

Options can include:

  • docetaxel
  • cabazitaxel
  • abiraterone
  • enzalutamide
  • PARP inhibitors
  • radioligand therapy
  • radium-223
  • selected immunotherapy
  • clinical trials.

Simply moving repeatedly from one androgen-receptor drug to another is becoming less attractive because of significant cross-resistance.

7. Genetic Testing Has Become Part of Treatment

One of the most important changes in advanced prostate cancer management is the move toward precision medicine.

Men with metastatic disease should increasingly be considered for tumour genomic testing and, where appropriate, germline genetic testing.

Important abnormalities include mutations involving:

BRCA1, BRCA2 and other homologous recombination repair (HRR) genes.

These mutations may make the cancer susceptible to PARP inhibitors.

Examples include:

  • olaparib
  • niraparib
  • talazoparib
  • rucaparib in appropriate settings.

Some PARP inhibitors can now be combined with androgen-receptor treatments in appropriately selected patients.

The 2026 EAU guidelines specifically recommend testing metastatic patients for somatic or germline HRR abnormalities because the results may directly change treatment.

In other words, we increasingly need to know not only where the prostate cancer has spread, but what is driving it genetically.

8. Immunotherapy: Exciting, But Not for Everyone

Immunotherapy has transformed several cancers, but prostate cancer has proved more resistant to conventional immune checkpoint therapy.

For the average patient with metastatic prostate cancer, immunotherapy is not currently routine first-line treatment.

However, there is an important exception.

Pembrolizumab

A small proportion of prostate cancers have abnormalities known as:

  • MSI-high
  • mismatch-repair deficient (dMMR)
  • or, in relevant jurisdictions, sufficiently high tumour mutational burden.

These cancers may respond to the immune checkpoint inhibitor pembrolizumab.

ASCO’s 2026 living guideline recognises clinical activity of pembrolizumab in selected MSI-high/mismatch-repair-deficient metastatic castration-resistant prostate cancer.

This is another reason why molecular testing has become important.

For unselected prostate cancer patients, however, large trials combining pembrolizumab with treatments such as docetaxel, enzalutamide or olaparib have not demonstrated the hoped-for survival improvement.

Immunotherapy therefore currently works best as a biomarker-selected treatment rather than a universal prostate cancer therapy.

Possible immune-related side effects include inflammation of normal organs, including:

  • thyroid dysfunction
  • skin inflammation
  • colitis and diarrhoea
  • hepatitis
  • pneumonitis
  • adrenal or pituitary abnormalities.

Although uncommon, some immune complications can be serious and require corticosteroid treatment.

9. PSMA Radioligand Therapy

Another major advance is lutetium-177 PSMA radioligand therapy, often written as ¹⁷⁷Lu-PSMA-617.

The treatment uses a molecule that recognises PSMA on prostate cancer cells and carries a radioactive isotope directly to those cells.

It is therefore rather like delivering radiation with a molecular address label attached.

For appropriately selected men with PSMA-positive metastatic castration-resistant prostate cancer, it can provide another life-prolonging systemic treatment option.

The exact timing of ¹⁷⁷Lu-PSMA therapy is evolving rapidly as clinical trial evidence matures and regulatory indications change. Current EAU and ASCO recommendations include it among established systemic options for appropriately selected mCRPC patients.

Potential side effects include:

  • fatigue
  • dry mouth
  • nausea
  • reduced blood counts
  • anaemia
  • thrombocytopenia.

10. Radium-223 for Bone-Dominant Disease

Prostate cancer has a particular tendency to spread to bone.

Radium-223 is a radioactive treatment that preferentially targets areas of increased bone turnover.

It may be appropriate for selected men with symptomatic bone-predominant metastatic castration-resistant prostate cancer without visceral metastases.

Its role needs to be carefully coordinated with other treatments and bone-health management.

11. Don’t Forget the Prostate Itself

It may seem strange to treat the prostate once cancer has already spread.

However, clinical studies have demonstrated that treating the primary prostate tumour with radiotherapy can improve outcomes in selected men presenting with low-volume metastatic disease.

The EAU therefore recommends prostate radiotherapy for appropriately selected patients presenting with low-volume metastatic hormone-sensitive prostate cancer.

This does not mean every man with metastatic prostate cancer should have prostate surgery or radiation. The benefit depends on the pattern and burden of metastatic disease.

12. Side Effects of Long-Term Hormonal Treatment

Because men may now live for many years with advanced prostate cancer, treatment side effects deserve almost as much attention as the cancer itself.

Long-term ADT may cause:

Sexual effects

Reduced libido, erectile dysfunction and loss of spontaneous erections are common.

Hot flushes

These can range from mildly annoying to profoundly disruptive.

Muscle loss

Testosterone suppression causes loss of muscle mass and strength unless actively countered.

Weight gain

Fat tends to accumulate particularly around the abdomen.

Metabolic changes

ADT can increase the risk of:

  • insulin resistance
  • diabetes
  • abnormal cholesterol
  • cardiovascular disease.

Bone thinning

Long-term ADT accelerates osteoporosis and increases fracture risk.

Current EAU guidance recommends formal assessment of osteoporosis risk, including DEXA scanning when commencing long-term ADT, together with appropriate bone protection.

Mood and cognition

Some men experience:

  • fatigue
  • low mood
  • reduced motivation
  • sleep disturbance
  • difficulty concentrating.

These symptoms deserve recognition and treatment rather than being dismissed as simply part of ageing.

Exercise Is Part of Cancer Treatment

Regular exercise is one of the most useful supportive treatments for men receiving long-term ADT.

A programme incorporating:

resistance training + aerobic exercise + balance work

can help preserve muscle, bone strength, cardiovascular fitness and independence.

Nutrition, weight management, smoking cessation, alcohol moderation and optimisation of cardiovascular risk factors should form part of long-term prostate cancer care.

Bone Health Matters

Men receiving prolonged ADT should have their fracture risk assessed.

Depending on bone density and metastatic involvement, treatment may include:

  • calcium and vitamin D when appropriate
  • resistance and weight-bearing exercise
  • bisphosphonates
  • denosumab.

Men receiving denosumab or bisphosphonates require appropriate calcium monitoring and usually dental assessment because of the uncommon but important risk of osteonecrosis of the jaw.

A New Way of Thinking About Metastatic Prostate Cancer

The old treatment pathway was fairly linear:

ADT → wait for progression → chemotherapy → another treatment.

Modern treatment looks very different.

It is increasingly:

Diagnose → accurately stage → molecularly profile → intensify treatment early → continuously reassess → select the next therapy according to previous treatment and tumour biology.

For some patients this means:

ADT + ARPI

For others:

ADT + docetaxel + darolutamide

or:

ADT + docetaxel + abiraterone

And later, depending on the tumour:

chemotherapy → PARP inhibition → PSMA radioligand therapy → radium-223 → selected immunotherapy or clinical trials.

There is no longer a single treatment pathway that suits every patient.

The Bottom Line

Advanced prostate cancer remains a serious disease, but its treatment has undergone a remarkable transformation.

The strongest contemporary evidence supports early treatment intensification for suitable men with metastatic hormone-sensitive prostate cancer rather than relying on ADT alone.

The ARASENS and PEACE-1 trials established an important role for triplet therapy in appropriately selected patients, while modern guidelines increasingly emphasise genomic testing, targeted treatment, radioligand therapy and careful sequencing of chemotherapy and androgen-receptor treatments.

Intermittent ADT is attractive from a quality-of-life perspective but is not the routine standard for metastatic disease, where continuous ADT-based combination treatment remains preferred.

Perhaps most importantly, treatment should not focus exclusively on the PSA.

Bone health, cardiovascular health, muscle strength, sexual health, psychological wellbeing and maintaining independence are all part of successful prostate cancer treatment.

For many men, metastatic prostate cancer can now be controlled for years through carefully planned sequences and combinations of treatment.

This information is intended for general patient education. Treatment of advanced prostate cancer should be individualised through discussion with a urologist, medical oncologist and radiation oncologist experienced in prostate cancer management.

Robotic-Assisted Radical Prostatectomy: When Is a Non-Nerve-Sparing Procedure Necessary?

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Removing the prostate while putting cancer control first

Robotic-assisted radical prostatectomy is a well-established surgical treatment for localised and selected locally advanced prostate cancer. During the operation, the prostate gland and seminal vesicles are removed, and the bladder is reconnected to the urethra. In selected patients, pelvic lymph nodes may also be removed.

One of the important decisions made before and during prostate cancer surgery is whether the nerves responsible for erections can safely be preserved.

This is known as nerve-sparing prostatectomy.

Unfortunately, nerve preservation is not always appropriate. When prostate cancer is close to, involves, or is suspected of extending beyond the outer edge of the prostate near these nerves, attempting to preserve them may compromise the completeness of cancer removal.

In this situation, a partial or complete non-nerve-sparing robotic prostatectomy may be recommended.

The guiding principle is simple:

Preserve the nerves when it is oncologically safe to do so, but do not preserve them at the expense of adequately treating the prostate cancer.

What are the nerves that are being “spared”?

Running immediately alongside the prostate are delicate bundles of nerves and blood vessels known collectively as the neurovascular bundles.

These structures contain nerves that play an important role in producing erections.

They sit extremely close to the outer surface, or capsule, of the prostate. This anatomical relationship creates a challenge during prostate cancer surgery.

If the cancer is safely contained within the prostate and sufficiently distant from the neurovascular bundle, the surgeon may be able to carefully dissect the prostate away while preserving the nerves.

This is a nerve-sparing radical prostatectomy.

If cancer is suspected to extend towards or through the prostate capsule in this area, the surgeon may need to remove some or all of the neurovascular tissue together with the prostate.

This is a non-nerve-sparing prostatectomy.

Why would a surgeon deliberately remove the erectile nerves?

It may initially seem counterintuitive to remove structures that are so important for sexual function.

The reason is cancer control.

The primary purpose of radical prostatectomy is to completely remove the prostate cancer.

If a tumour is growing very close to the edge of the prostate, particularly next to a neurovascular bundle, dissecting too close to the prostate in an attempt to preserve the nerves could potentially leave cancer cells behind.

This is called a positive surgical margin.

In appropriately selected patients, taking a wider margin around the prostate may therefore provide a safer cancer operation.

The decision represents a balance between:

Cancer control

and

preservation of erectile function.

When these two goals conflict, cancer control generally takes priority.

When may a non-nerve-sparing prostatectomy be recommended?

Non-nerve-sparing surgery may be considered when there is a significant risk that prostate cancer has extended towards or into the tissues surrounding the prostate.

Examples include:

Locally advanced prostate cancer

A tumour suspected of extending through the prostate capsule, particularly clinical T3 disease, may require a wider surgical excision.

Cancer close to the neurovascular bundle on MRI

Modern multiparametric prostate MRI can provide valuable information about the location of the tumour and its relationship to the prostate capsule and neurovascular bundles.

Features suggesting extraprostatic extension may influence the decision not to preserve the nerve bundle on that side.

High-grade prostate cancer

Higher-grade cancers, including cancers with an unfavourable Gleason score or ISUP Grade Group, may have a greater likelihood of extending outside the prostate.

The biopsy result alone does not automatically determine whether the nerves can be preserved, but it forms part of the overall assessment.

Extensive cancer on prostate biopsy

Large-volume disease, particularly when concentrated along the outer portion of the prostate near a neurovascular bundle, may make nerve preservation less appropriate.

Very high PSA or other high-risk features

PSA level, PSA density, biopsy findings, MRI appearance and clinical examination are considered together when estimating the likelihood of disease extending beyond the prostate.

Cancer involving one particular side of the prostate

Importantly, nerve sparing does not necessarily have to be “all or nothing.”

If the cancer is predominantly on one side, it may sometimes be possible to preserve the neurovascular bundle on the opposite side.

This is known as unilateral nerve sparing.

Nerve sparing is not simply YES or NO

Modern robotic prostate surgery is more nuanced than dividing operations into completely nerve-sparing and completely non-nerve-sparing procedures.

Depending on the location and extent of the cancer, surgery may involve:

  • Bilateral nerve sparing
  • Unilateral nerve sparing
  • Partial nerve sparing
  • Wider excision on one side and nerve preservation on the other
  • Complete bilateral non-nerve-sparing surgery

The surgical plan can therefore be tailored to the individual patient and, importantly, to the cancer on each side of the prostate.

How does nerve-sparing surgery differ from non-nerve-sparing surgery?

During nerve-sparing surgery, the surgeon carefully separates the neurovascular bundle from the surface of the prostate while attempting to minimise traction, heat and other potential injury to these delicate nerves.

During non-nerve-sparing surgery, the dissection is deliberately performed further away from the prostate.

The neurovascular tissue is removed together with the prostate where necessary to obtain a wider cancer margin.

The robotic platform provides magnified three-dimensional vision and highly controlled instrument movement. This allows the surgeon to identify tissue planes with considerable precision.

However, robotic technology cannot make an unsafe nerve-sparing operation safe.

The biology and location of the cancer ultimately determine how close to the prostate the surgeon can safely operate.

What happens to erections after non-nerve-sparing prostatectomy?

This is one of the most important issues to discuss before surgery.

The nerves surrounding the prostate are responsible for signalling increased blood flow into the penis to produce a natural erection.

If both neurovascular bundles are completely removed, the likelihood of recovering spontaneous erections adequate for sexual intercourse is very low.

This is different from nerve-sparing surgery, where the nerves remain anatomically intact but may temporarily function poorly following surgery.

After nerve-sparing prostatectomy, erectile recovery can occur gradually over many months and sometimes over 18–24 months or longer.

After complete bilateral non-nerve-sparing surgery, however, the nerves themselves have been removed rather than temporarily stunned.

The expectations for recovery are therefore very different.

Does non-nerve-sparing surgery affect sensation or orgasm?

This is an important distinction.

The nerves responsible for penile sensation are different from the neurovascular nerves primarily responsible for erections.

Many men can therefore continue to experience penile sensation and sexual pleasure following radical prostatectomy.

Orgasm may also remain possible.

However, radical prostatectomy removes the prostate and seminal vesicles and disconnects the reproductive pathway. Consequently, there is no ejaculation of semen after surgery.

This is sometimes described as a dry orgasm.

The sensation of orgasm can also feel different after prostate surgery.

Does non-nerve-sparing prostatectomy cause infertility?

Yes.

Radical prostatectomy results in permanent infertility because the prostate and seminal vesicles are removed and sperm can no longer enter the ejaculate.

Men who may wish to father children in the future should discuss sperm banking before surgery.

This applies whether the operation is nerve sparing or non-nerve sparing.

Is a non-nerve-sparing procedure reversible?

No.

Once a neurovascular bundle has been surgically removed, it cannot simply be reattached at a later date.

This is an important difference between temporary nerve dysfunction and actual nerve removal.

After nerve-sparing surgery, the nerves may be anatomically preserved but temporarily injured or “stunned”. Recovery may therefore occur with time.

After complete non-nerve-sparing surgery, the erectile nerves have been physically removed as part of the cancer operation.

The procedure itself is therefore not reversible.

However, this does not mean that erections or sexual activity are impossible.

There are several effective treatments available for erectile dysfunction following prostatectomy.

Can erections still be achieved after non-nerve-sparing surgery?

Rarely yes, but they will usually require assistance.

Treatment options include:

PDE5 inhibitor tablets

Medications such as sildenafil or tadalafil are commonly used after prostate surgery.

They rely substantially on functioning nerve pathways and are therefore generally more effective following nerve-sparing surgery.

Their effectiveness following complete bilateral non-nerve-sparing surgery is considerably more limited.

Vacuum erection device

A vacuum erection device creates negative pressure around the penis, drawing blood into the erectile tissues.

A constriction ring can then be placed around the base of the penis to maintain the erection.

Because this technique does not depend on intact erectile nerves, it can be useful after non-nerve-sparing surgery.

Penile injection therapy

Medication can be injected directly into the erectile tissue of the penis.

These medications act directly on penile blood vessels and therefore do not require normal prostate-associated nerve signalling.

For this reason, penile injections can be highly effective even after bilateral non-nerve-sparing prostatectomy.

Penile prosthesis

For men with persistent erectile dysfunction who wish to restore reliable erections, a penile prosthesis can provide an effective long-term solution.

An inflatable penile prosthesis allows an erection to be mechanically produced when desired.

For appropriately selected men, satisfaction rates following penile prosthesis surgery are generally high.

What about penile rehabilitation?

Penile rehabilitation may be discussed following radical prostatectomy.

The objectives can include maintaining penile tissue health, encouraging regular oxygenation of the erectile tissues, minimising shortening and fibrosis, and assisting the return to sexual activity.

A rehabilitation program may involve:

  • PDE5 inhibitor medication where appropriate
  • Vacuum erection therapy
  • Penile injection therapy
  • Regular sexual stimulation
  • Early assessment and management of erectile dysfunction

The appropriate program depends heavily on whether surgery was bilateral nerve sparing, unilateral nerve sparing or completely non-nerve sparing.

It is therefore important that expectations are realistic.

After complete bilateral nerve removal, rehabilitation cannot make the removed nerves grow back. Instead, treatment focuses on maintaining penile health and providing alternative ways of achieving an erection.

Can the surgeon decide during the operation whether to spare the nerves?

Sometimes.

The intended degree of nerve sparing is usually planned before surgery using information from:

  • Prostate MRI
  • Prostate biopsy
  • PSA
  • Clinical examination
  • Location and volume of cancer
  • Gleason score and ISUP Grade Group
  • Estimated risk of extraprostatic extension
  • The patient’s existing erectile function
  • The patient’s priorities regarding cancer control and sexual function

However, the final surgical approach may occasionally need to be modified according to findings encountered during the operation.

The most important objective remains adequate removal of the cancer.

Does non-nerve-sparing surgery improve cancer cure rates?

Not every patient benefits from wider surgery.

For men with cancer safely confined within the prostate, unnecessary removal of the neurovascular bundles may produce significant functional consequences without providing additional cancer benefit.

Conversely, when cancer is suspected of extending close to or beyond the prostate capsule adjacent to a neurovascular bundle, wider excision may reduce the risk of leaving tumour at the surgical margin.

This is why the decision must be individualised.

The best operation is not automatically the operation that preserves the most nerves. It is the operation that provides appropriate cancer clearance while preserving as much normal function as can safely be preserved.

What about urinary continence?

Nerve sparing primarily relates to erectile function, rather than the urinary sphincter responsible for continence.

Urinary control after radical prostatectomy depends on several factors including:

  • Age
  • Pre-operative urinary function
  • Pelvic floor strength
  • Urethral length
  • Bladder function
  • Surgical anatomy and technique
  • Previous prostate treatments
  • Individual healing

Pelvic floor rehabilitation before and after surgery can be an important part of recovery.

Non-nerve-sparing surgery does not automatically mean that a patient will remain incontinent.

Questions worth asking before surgery

If a non-nerve-sparing robotic prostatectomy has been recommended, useful questions to discuss with your urologist include:

Why is nerve preservation considered unsafe in my particular cancer?

Is the concern on one side or both sides of the prostate?

Could unilateral or partial nerve sparing be considered?

What does my MRI show about the relationship between the cancer and neurovascular bundles?

What is my estimated chance of erectile recovery with the proposed operation?

What erectile rehabilitation options will be available after surgery?

Should I consider sperm banking before treatment?

These conversations are particularly important because the decision to remove a neurovascular bundle is generally irreversible.

The important message

A non-nerve-sparing robotic-assisted radical prostatectomy is not an inferior version of nerve-sparing surgery.

In the right patient, it is a deliberate cancer-control strategy.

When prostate cancer is close to or suspected of involving the tissues surrounding the prostate, preserving the erectile nerves too aggressively may risk leaving cancer behind.

Modern robotic surgery allows the operation to be tailored to the individual patient. Some men can undergo bilateral nerve preservation, others may benefit from preservation on only one side, while patients with more extensive disease may require a wider non-nerve-sparing excision.

The consequences for erectile function are important and should be understood before surgery.

Once the neurovascular nerves have been removed, the procedure cannot be reversed.

However, loss of spontaneous erections does not mean the end of sexual intimacy. Vacuum devices, penile injection therapy and penile prostheses can provide effective options when natural erections are no longer possible.

Ultimately, the aim is to achieve the best possible balance between two important goals:

Effective treatment of the prostate cancer and preservation of quality of life.

A note for patients

Every prostate cancer is different. MRI findings, biopsy results, PSA, cancer grade, age, general health, pre-existing erectile function and personal priorities all influence the appropriate surgical approach.

A detailed discussion with your urologist before robotic prostatectomy is essential so that you understand whether nerve sparing is appropriate, what degree of nerve preservation may be possible and what this means for cancer control, continence and sexual function.

This information is intended for general patient education and does not replace individual medical advice. Treatment recommendations should be based on your individual prostate cancer characteristics, imaging, pathology, general health and discussion with your treating urologist.

Focal Therapy for Prostate Cancer: Treating the Cancer, Preserving the Prostate

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For many years, treatment of localised prostate cancer largely involved choosing between active surveillance and treatment of the whole prostate gland with surgery or radiotherapy.

Modern multiparametric MRI, targeted transperineal biopsy and increasingly accurate image-guided treatment have opened a third pathway for carefully selected men: focal therapy.

Rather than treating or removing the entire prostate, focal therapy aims to identify the clinically significant cancer and destroy that area together with an appropriate safety margin, while leaving as much normal prostate tissue as possible.

A useful analogy is treating the troublesome patch rather than replacing the entire lawn.

The attraction is obvious: if the cancer can be controlled without treating the whole prostate, it may be possible to reduce the risks of urinary incontinence, erectile dysfunction and other quality-of-life effects associated with radical treatment.

However, focal therapy is not suitable for every prostate cancer, and it comes with an important trade-off: long-term cancer-control evidence is less mature than it is for radical prostatectomy and radiotherapy. Current European guidance therefore remains cautious, recommending focal therapy within clinical trials or well-designed prospective registries until stronger long-term comparative evidence becomes available.

What is focal therapy?

Focal therapy treats a selected region of the prostate containing clinically significant cancer rather than treating the entire gland.

Depending on the size and location of the tumour, treatment may involve:

  • Focal ablation of an individual lesion
  • Hemi-ablation, treating approximately one side of the prostate
  • Quadrant or zonal ablation
  • A wider “hockey-stick” ablation where disease distribution requires a larger treatment field

The treatment zone normally includes both the visible tumour and a planned margin around it.

The challenge is that prostate cancer is frequently multifocal. The largest or most biologically significant lesion is often referred to as the index lesion, but smaller cancer deposits may exist elsewhere in the gland.

For this reason, careful imaging, biopsy and follow-up are fundamental to a successful focal therapy program.

Who may be suitable for focal therapy?

The ideal candidate is generally a man with localised, clinically significant prostate cancer that can be accurately identified and safely targeted.

Potential candidates may include men with:

  • Disease confined to the prostate
  • A clearly identifiable lesion on multiparametric MRI
  • Cancer confirmed by targeted and systematic or mapping transperineal biopsy
  • Favourable intermediate-risk disease, commonly ISUP Grade Group 2 / Gleason 3+4, in an appropriate anatomical distribution
  • Selected higher-volume Grade Group 1 disease where active surveillance is considered unsuitable or unacceptable
  • Occasionally carefully selected Grade Group 3 disease in experienced centres, although the evidence is less established
  • A lesion that can be treated with an adequate margin without unacceptable injury to the urethra, sphincter, rectum or neurovascular structures
  • A strong preference to minimise the potential urinary and sexual consequences of whole-gland treatment

The decision should ideally follow review of the MRI, biopsy pathology, PSA, PSA density, prostate volume, tumour location and overall risk profile, rather than simply asking whether a particular machine can reach the tumour.

Who is generally NOT a good candidate?

Focal treatment becomes less attractive when there is:

  • Extensive multifocal clinically significant cancer
  • Significant bilateral disease
  • High-volume high-grade cancer
  • Extracapsular extension
  • Seminal vesicle invasion
  • Lymph-node involvement
  • Metastatic disease
  • Cancer that cannot be reliably seen or mapped
  • Disease immediately adjacent to structures that cannot safely be included in the treatment margin
  • A patient preference for the treatment with the longest-established oncological follow-up

Some men with very low-risk disease may also be better served by active surveillance rather than focal treatment, avoiding treatment altogether until there is evidence that treatment is actually necessary.

How do we determine whether focal treatment is appropriate?

Successful focal therapy begins with accurate cancer mapping.

Assessment will usually include:

Multiparametric MRI

MRI identifies suspicious lesions and helps establish their size, location and relationship to the urethra, capsule, sphincter and neurovascular bundles.

Transperineal prostate biopsy

MRI alone is not enough.

Targeted biopsy confirms the grade and extent of the MRI-visible lesion, while systematic or mapping biopsies help determine whether significant cancer exists elsewhere in the prostate.

PSA and PSA density

PSA remains useful, although interpretation after focal therapy differs from interpretation following radical prostatectomy because normal prostate tissue remains behind.

PSMA PET/CT

PSMA PET may be useful in selected patients, particularly those with higher-risk characteristics or when there is concern about disease outside the proposed treatment area.

What focal therapy options are available?

Several technologies can destroy a selected area of prostate tissue.

These include:

Irreversible Electroporation: NanoKnife

NanoKnife® is a system used to perform irreversible electroporation, or IRE.

Several fine needle electrodes are inserted through the perineum around the tumour under imaging guidance. Very short, high-voltage electrical pulses are passed between the electrodes.

Rather than primarily heating or freezing the tissue, the electrical field creates irreversible disruption of cell membranes, resulting in cell death.

IRE is therefore principally considered a non-thermal ablative technology.

Focal Laser Ablation

A laser fibre is placed directly into the target lesion and laser energy produces controlled thermal destruction of cancerous tissue.

ProFocal-Rx® is an Australian-developed focal laser technology designed specifically for targeted prostate treatment.

High-Intensity Focused Ultrasound

HIFU focuses ultrasound energy within the prostate, heating and destroying the targeted tissue without requiring needles to be placed directly throughout the treatment zone.

Cryotherapy

Needles are placed into the prostate and tissue is repeatedly frozen and thawed, producing cellular destruction.

Other technologies

Photodynamic therapy, radiofrequency ablation, focal brachytherapy and other energy-based approaches have also been investigated.

The Prostate Cancer Foundation of Australia notes that focal therapies including IRE/NanoKnife, laser ablation, HIFU and other technologies have been investigated or used in Australia, although availability varies.

NanoKnife versus ProFocal Laser Therapy

Both technologies attempt to achieve the same broad objective: destroy the cancer while preserving as much normal prostate and surrounding function as possible.

They achieve this in very different ways.

NanoKnife / IRE ProFocal-Rx Laser
Energy High-voltage electrical pulses Laser energy
Mechanism Irreversible electroporation Thermal coagulative ablation
Thermal treatment Principally non-thermal Yes
Access Transperineal needles/electrodes Transperineal laser applicator
Treatment planning Electrode geometry surrounds treatment zone Laser applicator positioned within/adjacent to target
MRI/TRUS planning Yes Yes
Tissue effect Cell membrane disruption Controlled heating and tissue necrosis
Treatment margin Created by electrical field between electrodes Created by laser ablation zone
Near neurovascular structures Potential theoretical advantage of non-thermal mechanism Requires careful thermal planning
Anaesthesia General anaesthesia with profound muscle relaxation generally required General anaesthesia typically used
Cardiac synchronisation Required with IRE Not required in the same manner
Repeat treatment Possible in selected cases Potentially possible
Long-term oncological evidence Growing medium-term evidence Earlier-stage clinical evidence
Australian regulatory status IRE devices are represented on the ARTG; specific device/indication should be checked ProFocal is currently not included on the ARTG

NanoKnife: potential advantages

The major attraction of IRE is that it does not rely primarily upon heating or freezing the prostate.

The electrical field disrupts cell membranes while potentially allowing relative preservation of extracellular structures. This makes IRE particularly interesting when treating cancers close to delicate structures.

Potential advantages include:

  • Precise treatment planning
  • No ionising radiation
  • No prostate removal
  • Preservation of untreated prostate tissue
  • Low reported rates of significant urinary incontinence
  • Potentially better preservation of erectile function compared with whole-gland treatment
  • Ability to consider repeat focal treatment in selected patients
  • Radical surgery or radiotherapy may remain possible if subsequent clinically significant cancer develops

Australian and international experience with IRE is considerably more mature than that of many newer focal technologies, although long-term comparative data against radical prostatectomy and radiotherapy are still developing. Published reviews cited by the AUA report residual or recurrent clinically significant cancer after focal ablation across all technologies, reinforcing the need for surveillance rather than considering focal therapy a “treat it and forget it” procedure.

NanoKnife: disadvantages and potential complications

IRE is still an invasive procedure.

Potential complications include:

  • Temporary urinary frequency and urgency
  • Dysuria
  • Haematuria
  • Perineal bruising or discomfort
  • Urinary retention
  • Temporary catheter requirement
  • Urinary tract infection
  • Prostatitis
  • Urethral injury or stricture
  • Erectile dysfunction
  • Ejaculatory changes
  • Rare urinary incontinence
  • Incomplete tumour ablation
  • Residual cancer within the treated field
  • Development or recognition of cancer elsewhere in the prostate
  • Need for repeat focal treatment
  • Subsequent need for radical prostatectomy or radiotherapy

Because IRE uses high-voltage electrical pulses, treatment requires appropriate anaesthesia, muscle relaxation and cardiac synchronisation.

ProFocal-Rx: focal laser therapy

ProFocal-Rx is a targeted laser ablation system developed in Australia.

A treatment applicator is placed transperineally into the prostate tumour. Laser energy is then delivered into the planned treatment area, producing controlled thermal destruction.

Early Australian studies have evaluated the feasibility and safety of this approach, including clinical trials of targeted treatment for MRI-localised prostate cancer.

Potential attractions include:

  • Highly localised treatment
  • Direct placement of the treatment fibre into the tumour
  • Relatively small treatment volumes
  • Preservation of surrounding prostate tissue
  • Short treatment and recovery pathways
  • Potential preservation of urinary continence
  • Potential preservation of erectile and ejaculatory function

However, ProFocal remains a newer technology with substantially less long-term oncological follow-up than radical prostatectomy, radiotherapy and even some other focal therapy platforms.

ProFocal: potential risks and limitations

Because laser treatment is thermal, careful treatment planning is required to prevent unintended heat injury.

Possible complications include:

  • Urinary frequency or urgency
  • Dysuria
  • Haematuria
  • Temporary urinary retention
  • Infection
  • Perineal discomfort
  • Urethral thermal injury
  • Erectile dysfunction
  • Ejaculatory changes
  • Rectal injury, although uncommon with appropriate treatment planning
  • Incomplete ablation
  • Residual clinically significant cancer
  • Cancer developing or being detected elsewhere in the prostate
  • Need for repeat treatment
  • Need for subsequent radical prostatectomy or radiotherapy

An important additional consideration is simply the maturity of the evidence. Early results can be encouraging without necessarily predicting cancer control at 10, 15 or 20 years.

What is the TGA status in Australia?

This point deserves particular clarity.

The Australian Register of Therapeutic Goods (ARTG) is the TGA’s public register of therapeutic products that can legally be supplied in Australia, subject to applicable exemptions and special-access pathways.

IRE / NanoKnife

Irreversible electroporation technology is available in Australia and is being used clinically for selected prostate cancers. The Medical Services Advisory Committee currently has an application assessing IRE using the NanoKnife system for prostate tumour tissue, including a proposed Medicare Benefits Schedule item. That MSAC application remains under assessment rather than representing an established Medicare item.

It is important not to confuse TGA/ARTG regulatory status with Medicare funding or with endorsement of focal therapy as oncologically equivalent to prostatectomy or radiotherapy. These are separate questions.

ProFocal-Rx

As of August 2026, the manufacturer’s Australian website specifically states that:

ProFocal is not included on the TGA’s ARTG in Australia.

TGA documents also demonstrate previous Australian patient access to ProFocal-Rx through the Special Access Scheme, which is a pathway for accessing an unapproved therapeutic good in particular circumstances and is not the same as general ARTG inclusion.

This distinction is important when discussing ProFocal with Australian patients.

Regulatory status can change, so the current ARTG should always be checked when treatment is being considered.

Does focal therapy cure prostate cancer?

It can achieve local control of appropriately selected prostate cancers, but the word “cure” needs to be used carefully.

Unlike radical prostatectomy, focal therapy deliberately leaves much of the prostate behind.

There are therefore two important potential sites of future cancer:

In-field recurrence
Cancer persists or recurs within the treated area.

Out-of-field cancer
Clinically significant cancer is subsequently detected elsewhere in the untreated prostate.

Neither necessarily means that focal therapy was inappropriate, but patients need to understand from the outset that continued prostate cancer surveillance is part of the treatment strategy.

The AUA’s salvage guideline notes clinically significant cancer following focal treatment across different modalities and emphasises that recurrence remains an important consideration after focal ablation.

Follow-up after focal therapy

Focal therapy does not end prostate cancer surveillance.

Follow-up typically involves a combination of:

  • Regular PSA testing
  • Clinical review
  • Multiparametric MRI
  • Repeat targeted and systematic biopsy
  • Additional imaging where clinically indicated

A common strategy is to establish a new PSA baseline after treatment and combine PSA behaviour with MRI and scheduled biopsy rather than relying on PSA alone.

This is important because the remaining normal prostate continues to produce PSA. Unlike after radical prostatectomy, the PSA is therefore not expected to become undetectable.

What happens if the cancer returns?

One of the advantages of focal treatment is that further treatment options usually remain available.

Depending upon the location, grade and extent of recurrent disease, options may include:

  • Continued surveillance for insignificant disease
  • Repeat focal therapy
  • Radical prostatectomy
  • External-beam radiotherapy
  • Other appropriate salvage treatment

Patients should nevertheless understand that salvage surgery after previous focal therapy may be technically more challenging because of fibrosis and altered tissue planes.

For clinically significant recurrence following focal ablation, AUA salvage guidance recommends that men considering definitive salvage treatment be offered whole-gland treatment with radical prostatectomy or radiotherapy.

Focal therapy versus radical treatment

Focal therapy occupies an increasingly interesting middle ground.

Active surveillance aims to avoid treatment until treatment becomes necessary.

Focal therapy aims to treat the clinically significant cancer while preserving the remainder of the prostate.

Radical prostatectomy or radiotherapy aims to treat the entire prostate and therefore both known and potentially occult cancer within the gland.

There is no universally “best” choice.

The appropriate treatment depends upon:

  • Cancer grade
  • Cancer volume
  • MRI findings
  • Biopsy distribution
  • PSA and PSA density
  • Age and life expectancy
  • Baseline urinary function
  • Baseline erectile function
  • Other medical conditions
  • Individual attitude towards cancer risk
  • Willingness to undergo continued MRI and biopsy surveillance
  • Personal priorities regarding continence and sexual function

The key question: are we treating the right cancer?

The success of focal therapy depends less on the glamour of the machine and more on patient selection, accurate imaging, meticulous biopsy mapping, treatment planning and rigorous follow-up.

NanoKnife, laser, HIFU and cryotherapy are different tools. The most important step occurs before any of them are switched on: establishing exactly where the clinically significant cancer is and whether disease elsewhere in the prostate has been adequately excluded.

For the appropriately selected man, focal therapy offers an attractive possibility:

Treat the cancer that needs treatment while preserving as much of the prostate, urinary function and sexual function as possible.

For other men, active surveillance, radical prostatectomy or radiotherapy will remain the safer oncological strategy.

Important perspective

Focal therapy is an exciting and rapidly evolving field, but it should not be presented as a universally equivalent replacement for established prostate cancer treatments.

Current evidence suggests good functional outcomes in appropriately selected patients, while definitive long-term comparative oncological evidence remains incomplete. European guidelines consequently continue to recommend focal therapy within clinical trials or prospective registries.

The decision is therefore best made after a detailed discussion with a urologist experienced in prostate MRI, transperineal biopsy, focal therapy and established radical treatment options.

Australian regulatory note

At the time of writing in August 2026, ProFocal-Rx is not included on the Australian ARTG, while IRE/NanoKnife technology is available in Australia and IRE for prostate cancer is currently undergoing an MSAC assessment relating to proposed Medicare funding. Regulatory status and funding arrangements may change and should be confirmed before treatment.

This information is intended for general patient education and does not replace individual medical advice. Suitability for focal therapy requires assessment of the patient’s pathology, imaging, prostate anatomy, overall health and personal treatment priorities.

Active Surveillance for Prostate Cancer

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Being diagnosed with prostate cancer does not always mean that treatment needs to start immediately.

Many prostate cancers grow very slowly and may never cause symptoms or threaten a man’s life. For carefully selected men, active surveillance allows the cancer to be closely monitored while avoiding, or at least delaying, treatments such as surgery or radiation therapy.

Importantly, active surveillance does not mean ignoring the cancer. It is a structured programme of PSA testing, clinical review, prostate MRI and, when appropriate, repeat prostate biopsy. If there are signs that the cancer is becoming more significant, treatment can be recommended while the disease is still potentially curable.

Current international guidelines consider active surveillance the preferred or standard management approach for most suitable men with low-risk localised prostate cancer, and it may also be considered in carefully selected men with favourable intermediate-risk disease.

What Is Active Surveillance?

Active surveillance is a management strategy for prostate cancer in which curative treatment is deliberately postponed while the cancer is carefully monitored.

The aim is simple:

Avoid unnecessary treatment and its potential side effects, without compromising the opportunity for cure if the cancer changes.

This is particularly relevant because prostate cancer behaves very differently from one man to another. Some cancers are aggressive and require treatment, while others may remain small and slow-growing for many years.

Australian patient guidance describes active surveillance as close monitoring of low-risk prostate cancer that is not causing symptoms, with treatment initiated if investigations indicate that the cancer is becoming more aggressive.

Who Qualifies for Active Surveillance?

Active surveillance is most commonly recommended for men with low-risk prostate cancer.

Typical features include:

  • Cancer confined to the prostate
  • Grade Group 1 / Gleason score 3+3=6
  • PSA generally less than 10 ng/mL
  • Clinical stage T1 to T2a
  • Relatively small volume of cancer on prostate biopsy
  • Favourable findings on multiparametric MRI
  • A PSA density that supports low-volume disease
  • No clinical or imaging evidence suggesting more aggressive cancer

The AUA/ASTRO risk classification defines low-risk disease as PSA below 10 ng/mL, Grade Group 1 and clinical stage T1–T2a. For these patients, active surveillance is recommended as the preferred management strategy.

However, no single number determines suitability. Age, general health, family history, MRI findings, PSA density, biopsy findings, life expectancy and personal preferences all contribute to the decision.

Can Men With Gleason 3+4 / Grade Group 2 Cancer Have Active Surveillance?

Sometimes.

Active surveillance is increasingly considered for carefully selected men with favourable intermediate-risk prostate cancer, particularly when there is only a small amount of Gleason pattern 4 disease.

The 2026 European Association of Urology guidelines support active surveillance for selected men with favourable Grade Group 2 cancer. Features favouring surveillance include a small amount of pattern 4 disease, PSA below 10 ng/mL, limited tumour volume on biopsy and favourable imaging.

Similarly, AUA/ASTRO guidance suggests that favourable intermediate-risk patients with low PSA density, low tumour volume and a low percentage of Gleason pattern 4 disease may be considered for active surveillance.

These men require careful counselling because their risk of progression is higher than for men with Grade Group 1 disease.

Active surveillance is generally not appropriate for Grade Group 3 or higher-risk prostate cancer in men otherwise suitable for curative treatment.

What Happens Before Starting Active Surveillance?

The first step is making sure that the cancer really is suitable for surveillance.

Assessment may include:

PSA and PSA Density

PSA is considered together with prostate volume to calculate the PSA density.

A relatively low PSA density, commonly around less than 0.15 ng/mL/cc, provides additional reassurance in men being considered for surveillance, although it should not be interpreted as an absolute cut-off in isolation.

Multiparametric MRI of the Prostate

A high-quality multiparametric MRI (mpMRI) provides important information about:

  • The location of the tumour
  • Tumour size
  • Suspicious areas within the prostate
  • Possible extension outside the prostate
  • Areas that should be targeted during biopsy

MRI has become an important part of modern active surveillance, but MRI alone does not completely replace prostate biopsy.

Review or Confirmation of the Biopsy

The initial biopsy determines the Grade Group, Gleason score and volume of cancer.

Depending on how the original diagnosis was made, a confirmatory biopsy may be recommended. MRI-targeted biopsies can specifically sample suspicious lesions, while systematic or regional biopsies assess other areas of the prostate.

How Is Active Surveillance Performed?

Active surveillance is an ongoing programme rather than a single test.

The exact protocol varies according to the patient’s age, cancer characteristics, previous investigations and the treating urologist or institution.

A typical programme may include:

PSA Testing

PSA is usually measured approximately every 3–6 months initially, although intervals may become longer in men with very stable disease.

Current EAU guidance recommends PSA testing at least every six months, while Australian Cancer Council information describes PSA testing every 3–6 months.

The trend in PSA is usually more informative than one isolated reading.

An unexpected rise does not automatically mean that the cancer has progressed. PSA can fluctuate because of benign prostate enlargement, inflammation, infection and other factors.

For this reason, an unexpected PSA rise will often be repeated before further decisions are made.

Clinical Review

Regular appointments allow your urologist to review:

  • PSA changes
  • Urinary symptoms
  • General health
  • Examination findings
  • MRI results
  • Whether further investigation is required

A digital rectal examination may form part of surveillance, although its frequency can be individualised.

Repeat Prostate MRI

Repeat mpMRI may be performed periodically or earlier if PSA or other findings become concerning.

MRI allows comparison with previous scans to determine whether a lesion is:

  • Stable
  • Increasing in size
  • Becoming more suspicious
  • Showing features suggesting progression

Importantly, a change on MRI will often lead to a repeat biopsy rather than automatically triggering treatment. The EAU recommends confirming suspected histological progression before changing treatment strategy where appropriate.

Repeat Prostate Biopsy

Repeat biopsy remains an important component of active surveillance.

The frequency varies according to individual risk, previous MRI and biopsy findings and the surveillance protocol being followed.

The biopsy may involve:

  • Targeted biopsy of an MRI abnormality
  • Systematic sampling
  • A combination of targeted and regional/systematic biopsies

Modern surveillance programmes increasingly tailor biopsy frequency according to the individual’s risk rather than applying exactly the same schedule to every patient.

What Are We Looking for During Surveillance?

The purpose of surveillance is to identify reclassification or progression before the cancer becomes difficult to cure.

Your urologist will be looking for several possible warning signs.

These include:

Increasing cancer grade

For example, a cancer initially classified as Grade Group 1 may subsequently demonstrate a significant amount of Gleason pattern 4 disease.

Increasing cancer volume

More biopsy samples may contain cancer, or individual samples may contain a greater amount of cancer.

Changes on MRI

An existing lesion may enlarge or become more suspicious, or a new lesion may appear.

Persistent PSA changes

A progressively increasing PSA, particularly when accompanied by increasing PSA density or concerning MRI findings, may trigger further investigation.

Clinical progression

Changes on examination or other investigations may suggest that the cancer is no longer behaving as expected.

When Should Active Surveillance Stop?

Active surveillance should generally continue for as long as the cancer remains suitable for surveillance and curative treatment remains relevant.

The decision to move to treatment should ideally be based on the overall picture rather than PSA alone.

Treatment may be recommended when there is:

  • Significant upgrading of the cancer on repeat biopsy
  • Increasing amounts of higher-grade cancer
  • Significant increase in tumour volume
  • Concerning progression on MRI confirmed by appropriate investigation
  • Evidence suggesting progression beyond the original low-risk category
  • A change in the patient’s preference after informed discussion

AUA/ASTRO guidance recommends that significantly higher-volume or higher-grade disease on surveillance biopsy should prompt discussion about definitive therapy.

What Happens If the Cancer Progresses?

The important concept behind active surveillance is that treatment has been postponed, not abandoned.

If investigations demonstrate clinically significant progression, curative treatment can be considered.

Depending on the man’s age, general health, cancer characteristics and preferences, options may include:

Radical Prostatectomy

Surgical removal of the prostate, increasingly performed using robotic-assisted radical prostatectomy.

Focal therapy

Nanoknife electroporation

ProFocal laser ablation

Radiation Therapy

Options may include:

  • External beam radiation therapy
  • Stereotactic radiation therapy in appropriate patients
  • Brachytherapy in selected cases
  • Radiation combined with hormonal therapy where clinically indicated

Other Selected Treatments

In carefully selected circumstances, other approaches may be discussed. The evidence for focal ablative therapies remains less mature than that for established treatments such as surgery and radiation therapy, and suitability needs individual assessment.

What Are the Benefits of Active Surveillance?

For appropriately selected men, the major advantage is avoiding treatment that may never have been necessary.

Avoiding or Delaying Treatment Side Effects

Radical treatment can potentially cause:

  • Urinary incontinence
  • Erectile dysfunction
  • Ejaculatory changes
  • Urinary symptoms
  • Bowel symptoms following some forms of radiation therapy

Active surveillance allows men to maintain their existing urinary, sexual and bowel function for longer.

Maintaining Quality of Life

Many men can continue normal work, exercise, travel and sexual activity without the recovery period or functional consequences associated with immediate treatment.

Avoiding Overtreatment

Some low-risk prostate cancers may never become clinically significant during a man’s lifetime.

Treating every prostate cancer immediately would therefore expose some men to treatment complications without providing a meaningful survival advantage.

Treatment Remains Available

Active surveillance preserves the opportunity for curative treatment if the cancer subsequently demonstrates significant progression.

Long-term outcomes from well-conducted active surveillance programmes are reassuring. The EAU reports 10-year prostate cancer-specific survival rates of approximately 98–100% in active surveillance cohorts, although outcomes depend on appropriate patient selection and follow-up.

What Are the Risks of Active Surveillance?

Active surveillance is not completely risk-free.

The Cancer May Progress

Some cancers initially thought to be low risk will subsequently demonstrate more aggressive features.

In fact, a significant proportion of men are eventually reclassified during long-term surveillance and may proceed to treatment.

The Initial Biopsy May Underestimate the Cancer

A prostate biopsy samples only part of the prostate.

Occasionally, higher-grade cancer may already be present but was not captured during the original biopsy. Modern MRI and targeted biopsy techniques help reduce this risk but cannot eliminate it completely.

Small Risk of Losing the Optimal Window for Treatment

This is one of the main reasons that regular follow-up is essential.

In appropriately selected men who comply with structured surveillance, the risk is low, but surveillance must be active rather than passive.

Repeat Investigations

Active surveillance may involve:

  • Repeated blood tests
  • MRI scans
  • Urology appointments
  • Repeat prostate biopsies

Biopsies can cause discomfort, bleeding and infection, although contemporary transperineal biopsy techniques can substantially reduce the risk of serious infection.

Psychological Impact

Some men find living with untreated cancer surprisingly easy. Others find it difficult.

Anxiety may occur around:

  • PSA tests
  • MRI scans
  • Repeat biopsies
  • Waiting for results
  • Concern that the cancer may be progressing

For some men, the psychological burden becomes an important factor when deciding whether to remain on surveillance.

Active Surveillance Is Not the Same as Watchful Waiting

These terms are sometimes confused, but they describe different approaches.

Active surveillance is generally used for men with potentially curable prostate cancer. The cancer is actively monitored, with the intention of offering curative treatment if clinically significant progression occurs.

Watchful waiting is more commonly used in older men or men with significant other medical conditions where prostate cancer is unlikely to affect life expectancy. Monitoring is less intensive, and treatment is generally introduced to control symptoms rather than with the intention of cure.

Does Active Surveillance Mean Doing Nothing?

No.

This is perhaps the most important misconception about active surveillance.

A better description might be:

“Treatment if and when it becomes necessary.”

The cancer is being monitored carefully so that unnecessary treatment can be avoided while retaining the opportunity to intervene if its behaviour changes.

For the right patient, this can provide an excellent balance between cancer control and preservation of quality of life.

The Bottom Line

Active surveillance has become an established standard of care for appropriately selected men with low-risk prostate cancer and can also be considered for some men with carefully selected favourable intermediate-risk disease.

The decision should take into account:

  • PSA and PSA density
  • Grade Group and Gleason score
  • Amount of cancer found on biopsy
  • MRI findings
  • Clinical stage
  • Age and life expectancy
  • General health
  • Family and genetic risk factors
  • Personal preferences

Most importantly, active surveillance requires a partnership between the patient and his urologist.

The goal is not simply to avoid treatment.

The goal is to avoid treatment that is unnecessary, while identifying the point at which treatment becomes worthwhile.

This information is intended for general education and does not replace individual medical advice. Recommendations for prostate cancer management should be based on a detailed assessment of the individual patient, pathology, PSA results, imaging, general health and personal preferences.