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Success Rates & Clinical Evidence

Focal therapy was first described to treat prostate cancer almost 20 years ago, and since then, many thousands of people have benefitted from focal treatments. In the UK, focal therapy is approved by NICE with the provision that data must be reported for monitoring purposes. This means that we have lots of data on how focal therapy has improved outcomes.


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Nice Approved
NICE Approved
2,186
Focal Therapy ​
Treatments Completed
Nice Approved
Avoid Incontinence​
and Erectile problems

Focal Therapy Timeline

1990–1995
Origins of Focal Therapy
The idea of focal therapy takes shape: Gary Onik performs the first ultrasound-guided prostate cryosurgery (1990), while HIFU treatment begins in France with the Ablatherm device (1995). These early trials mark the start of precision prostate cancer management.
2000–2005
Pioneers Establish the Concept
Innovative clinicians pioneer focal and partial-gland treatments. Vallancien’s European multicentre trial treats 559 patients, laying the foundation for image-guided focal therapies. Focal therapy trials begin at University College London Hospital, supported by advances in MRI and transperineal biopsy techniques.
2005–2012
Feasibility and Early Clinical Studies
Clinical studies confirm safety and efficacy. The UK HEAT registry begins collecting data (2005). A landmark UCLH Lancet Oncology study (2012) demonstrates cancer control with preserved urinary and sexual function, establishing a strong evidence base.
26 April 2012
First NICE Recognition (IPG424)
NICE publishes IPG424, recognising focal HIFU for localised prostate cancer under special arrangements. This marks formal acceptance by the UK’s health authority and enables structured clinical use with mandatory data collection.
February 2022
HEAT Registry: Largest Evidence Base
European Urology publishes 7-year outcomes from 1,379 patients across 13 UK centres. Results show 100% metastasis-free survival and 69% failure-free survival at 7 years, with excellent functional outcomes. This is the most robust dataset for focal HIFU worldwide.
2015–2023
Global Regulatory Recognition
FDA clears Sonablate HIFU in the USA (October 2015). NICE updates HIFU guidance (IPG756) and approves NanoKnife/IRE (IPG768, July 2023). HEAT registry data confirm durable long-term cancer control and safety across large cohorts.
2024 and beyond
Expanding Global Access
FDA clears NanoKnife (December 2024). Over 100,000 patients treated worldwide. Ongoing registry follow-up and randomised trials continue to expand access and strengthen international long-term validation.

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    NICE approval of focal therapy

    To make a decision about HIFU and NanoKnife, NICE reviewed all the data available for them in 2022, including comparing when they were used focally (to target just your tumour) and for your whole gland.

    It found that overall survival was higher for people treated with HIFU, compared with radical treatments (97.5% compared with 93.4%). There was a statistically significantly lower incidence of incontinence with focal HIFU compared with whole-gland HIFU. There was a statistically significantly lower incidence of erectile dysfunction with focal HIFU compared with whole-gland HIFU.

    Overall survival was also higher for people treated with NanoKnife, compared with radical treatments (99-100% compared with 93.4%). In people fully continent before their procedure, there was generally no incontinence 12 months afterwards. For people that were able to get and maintain erections before their procedure, between 3-7% of people had difficulty doing so 12 months after their procedure. However, there is only a limited number of data available for NanoKnife treatments, as it is newer than HIFU.

    At one year after one focal therapy treatment

    Of clinically significant cancer is eliminated*

    Of men are fully continent*

    Of men retain erections*

    *Based upon a review of 270 patients who all had treatment at The Focal Therapy Clinic using advanced MRI-ultrasound fusion technology to ensure treatment accuracy

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    HEAT and ICE registries

    The HEAT and ICE registries collect data on everyone who has had focal therapy in the UK. The HEAT registry logs people who receive HIFU and the ICE registry tracks those who receive cryotherapy. There are similar registries for people in Europe and the US.

    All surgeons and health centres in the UK can access the anonymised data held in these registries. As of September 2020, the registries hold data for over 3,200 people in the UK, from 18 clinical centres. This data will be used to understand long-term outcomes for people who are treated with these procedures


    Frequently asked questions

    When was focal therapy approved in the UK?
    Focal therapy using HIFU received formal recognition from NICE on 26 April 2012 through guidance IPG424, allowing UK centres to offer focal HIFU within structured data-collection programmes.

    The approval required:
    - Special arrangements for clinical governance
    - Informed patient consent regarding uncertainties
    - Prospective data collection in registries

    In 2023, NICE updated this guidance (IPG756), strengthening support based on a decade of evidence. NICE also approved NanoKnife (IRE) in July 2023 (IPG768).

    Key milestones:
    - 2005: UK centres begin HEAT registry data collection
    - April 2012: NICE IPG424 recognises focal HIFU
    - 2023: NICE updates HIFU guidance (IPG756) and approves NanoKnife (IPG768)

    The 2012 Lancet Oncology study by Ahmed et al. was pivotal in securing this recognition.
    How did MRI imaging impact the development of focal therapy?
    MRI imaging transformed focal therapy from concept to viable clinical treatment. Before mpMRI, prostate cancer was considered too diffuse and unpredictable to target accurately.

    MRI enabled focal therapy by providing:
    - Precise localisation of prostate tumours
    - Detailed treatment planning through 3D mapping
    - Improved targeting accuracy using MRI-ultrasound fusion
    - Reliable post-treatment surveillance without repeated biopsies

    A 2021 Radiology publication by Dr Clare Allen and Dr Francesco Giganti noted that mpMRI is essential for patient selection, planning, and follow-up.

    The PI-FAB scoring system, developed by FTC specialists, standardised interpretation of post-treatment MRI scans, helping detect recurrence and differentiate it from healing changes.

    Without advances in MRI, focal therapy would not have been possible; imaging made precision targeting achievable.
    What were the most important clinical trials that established the effectiveness of focal therapy?
    Several landmark studies established the effectiveness of focal therapy:

    Ahmed et al., Lancet Oncology (2012)
    The pivotal prospective study demonstrating focal HIFU's feasibility and early cancer control.

    Multicentre 5-Year Outcomes Study (2018)
    625 patients showed 100% cancer-specific survival, 98% metastasis-free survival, and 98% pad-free continence.

    HEAT Registry (2022)
    The largest dataset: 1,379 patients, up to 15 years' follow-up, 100% metastasis-free survival at 7 years, and excellent functional outcomes.

    PRESERVE Trial (2025)
    121 NanoKnife patients with intermediate-risk disease. Results led to FDA clearance in 2024 with high negative biopsy rates and low complications.

    Propensity-Matched Comparison (2021)
    Demonstrated equivalent 8-year cancer control to radical prostatectomy but with superior functional outcomes.
    How many people have been treated with focal therapy?
    Based on registry data and systematic reviews, an estimated 100,000–120,000 patients worldwide have undergone focal therapy for prostate cancer.

    By treatment type:
    HIFU80,000–90,000Manufacturer registries
    Cryotherapy15,000–20,000COLD Registry, reviews
    NanoKnife (IRE)5,000–8,000Single-centre and trial data

    Evidence in published research:
    - 2025 meta-analysis: 4,615 patients across 50 studies
    - 2024 meta-analysis: 49 cohorts
    - 2021 review: 5,827 patients across 72 studies
    - 2023 review: 8,000+ patients across 124 studies

    UK data:
    - HEAT Registry: 1,379 patients (2005–2020)
    - FTC consultants have contributed to research covering over 2,000 patients

    Global uptake is growing by around 7,000–8,500 new cases per year.
    How successful is focal therapy compared to prostate surgery?
    Research shows focal therapy achieves cancer control equivalent to radical prostatectomy while preserving urinary and sexual function far better.

    Cancer control at 5 years:
    Cancer-specific survival99–100% (FT)95–98% (RP)
    Metastasis-free survival98–100% (FT)95–98% (RP)
    Failure-free survival82–88% (FT)75–85% (RP)

    A propensity-matched study showed equivalent 8-year cancer control for both treatments.

    Functional outcomes:
    Pad-free continence93–100%60–85%
    Erectile function preserved75–98%13–67%
    Recovery timeDays to 2 weeks4–6 weeks

    One study showed HIFU patients had a 90% lower probability of incontinence compared with surgery. Focal therapy can also be repeated if needed, whereas repeat surgery is not possible once the prostate has been removed.
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    Any questions?

    If you’ve got any questions about your prostate cancer diagnosis or want to know more about HIFU or NanoKnife, don’t hesitate to get in touch with our friendly, knowledgeable team.

    0207 036 8870

    info@thefocaltherapyclinic.co.uk

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      Reference List

      HEAT Registry (European Urology, 2022) - Dudderidge T, et al. PMID: 35123819

      5-Year Multicentre Outcomes (European Urology, 2018) - Guillaumier S, et al. PMID: 29960750

      Focal vs Radical Prostatectomy Comparison (2021) - Tay KJ, Laniado M, Nigam R, et al.

      Ahmed Lancet Study (Lancet Oncology, 2012) - Ahmed HU, Allen C, et al. PMID: 22512844

      MRI and Focal Therapy (Radiology, 2021) - Allen C, Giganti F, et al. PMID: 33533678

      PI-FAB Scoring System (Eur Urol Oncol, 2023) - Giganti F, Allen C, et al. PMID: 37210343

      PRESERVE Trial (European Urology, 2025) - PMID: 40685282

      2025 Meta-analysis (Eur Urol Oncol) - PMID: 40251100

      2024 Meta-analysis (Prostate Cancer Prostatic Dis) - PMID: 39468217

      2021 Systematic Review (European Urology) - PMID: 34489140

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