Tag Archive for: focal therapy

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

/0 Comments/in , /by

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

/0 Comments/in , /by

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

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

/0 Comments/in , /by

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.