Leading the research into Focal Therapy for Prostate Cancer

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.


Mr Marc Laniado explains how focal therapy has been tested

Why research into Focal Therapy matters

As technology, imaging, and patient selection methods continue to advance, focal therapy is emerging as a credible, evidence-supported option within the modern landscape of prostate cancer management.

  • Focal therapy is supported by growing peer-reviewed research
  • Real-world outcomes are now available from thousands of patients
  • Our clinic is a contributor to ongoing clinical studies
...We test the tissues to see if the technology can actually destroy what we're aiming to destroy...
Mr. Marc Laniado, Lead consultant

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    Summary of clinical evidence

    Long-term cancer-control rates

    In a prospective registry of 1,379 men treated with focal therapy (primarily HIFU), overall survival at 7 years was ~97% (95% CI 96-99%).

    Source
    Rates of preserved sexual and urinary function

    Urinary continence (pad-free) after FT: reported rates ~95-100% in treatment-naïve (primary) settings.

    Source
    Recurrence & retreatment flexibility

    FT provides a “step-wise” approach — if recurrence occurs, whole-gland treatments remain possible; retreatment flexibility is a key feature.

    Source
    Guideline endorsements / regulatory status

    The National Institute for Health and Care Excellence (NICE) issues official guidance (IPG756) recognising focal HIFU as a treatment option for localised prostate cancer.

    Source
    Book an Evidence Review Consultation

    Clinical Trials Supporting Focal Therapy

    Focal therapy trials consistently show good mid-term cancer control (65–90%), very high continence rates (~95–100%), and strong erectile function preservation (~70–85%). Evidence is largely Level II–III, reflecting high-quality prospective but mostly non-randomised data.


    Study / Type Main Outcomes Evidence Level*
    HIFI Study (HIFU vs Radical Prostatectomy)
    Prospective, multicentre (n = 3,328)
    30-month salvage-free survival: ~90% (HIFU) vs 86% (RP); better urinary & sexual outcomes with HIFU Level II
    Multicentre Feasibility Trial (HIFU)
    Prospective, 51 patients
    94% avoided whole-gland treatment at 2 years; continence and QoL maintained Level III
    Pooled Analysis (Albisinni et al.)
    7 studies, 366 men
    Negative biopsy 87%; potency 74%; continence 96% Level III
    3-Year Prospective Study (HIFU)
    Single-centre, 91 men
    Failure-free survival: ~65–70% at 3 years; cancer-specific survival 100% Level III
    Systematic Review (2010–2020)
    50+ patient studies
    In-field recurrence ≤ 22%; continence ~98%; erectile function ~80% Level II

    *Evidence levels approximate:
    • Level II: well-designed non-randomised comparison studies
    • Level III: prospective single-arm or pooled analyses
    How focal therapy patients are monitored to ensure long-term safety

    Read Article
    How focal therapy outcomes compare to established treatments at 5-10 years

    Read Article
    Why long-term data is still emerging for focal therapy

    Read Article
    One Year Outcomes After MRI-Fusion HIFU at The Focal Therapy Clinic

    Read Article

    Our Clinic’s Role in Prostate Cancer Research

    At The Focal Therapy Clinic, we are honoured to play a role in this through participation of our consultations and patients in this research.

    Active involvement in clinical trials

    For over 25 years our consultants have participated in groundbreaking clinical trials into focal therapy and prostate cancer treatments. These include seminal trials into the effectiveness of Focal Therapy versus radical treatment.  

    Contribution to UK and global data registries

    All Focal Therapy Clinic cases are recorded in national and international patient directories. We have supported their development and ongoing maintenance. Our results have been included in multiple research papers 

    Collaboration with leading research bodies

    We audit our clinical results and benchmark them rigorously against others. We have ongoing relationships with leading UK academic institutes but also the American and European Focal Therapy Society members.

    Book an Evidence Review Consultation

    Hear from some of our patients about the effect focal therapy has had on their lives.

    Focal therapy patient sits at dining room table

    Steve’s Story

    Watch video 

    Dave’s Story

    Watch video 

    Guy’s Story

    Watch video 

    Frequently asked questions

    Is focal therapy clinically proven?
    Yes, focal therapy is clinically proven and NICE-approved for treating localised prostate cancer. Large-scale studies, including the HEAT registry of 1,379 patients with up to 15 years of follow-up, show excellent outcomes.

    Key clinical evidence includes:
    - 99–100% cancer-specific survival at 5 years
    - 98% metastasis-free survival at 5 years
    - Over 90% cancer-free at one year based on MRI and PSA
    - NICE approval for HIFU (IPG756, IPG424) and NanoKnife IRE (IPG768)

    Consultants at The Focal Therapy Clinic, including Mr Tim Dudderidge and Mr Raj Nigam, have published widely in leading journals such as European Urology and The Lancet, strengthening the evidence base.

    Focal therapy delivers cancer control comparable to radical prostatectomy while preserving urinary continence and erectile function to a far greater degree.

    Book a consultation to explore suitability.
    How many studies support focal therapy?
    More than 50 prospective studies involving over 8,000 patients support the effectiveness of focal therapy. Evidence includes large registries, systematic reviews, meta-analyses, and studies in top medical journals.

    Major evidence sources include:
    - HEAT Registry: 1,379 patients with up to 15 years of follow-up
    - 5-Year Multicentre Study: 625 patients with 100% cancer-specific survival
    - 2025 Meta-Analysis: 50 studies with 4,615 patients
    - 2024 Systematic Review: 49 cohorts across HIFU, NanoKnife, and cryotherapy

    Research published in Nature, The Lancet, and European Urology shows:
    - 86% recurrence-free survival at 12 months
    - 82% radical treatment-free survival at 5 years
    - 98% overall survival

    Consultants at The Focal Therapy Clinic help shape this evidence through ongoing publications and protocol development.
    What are the long-term outcomes for focal therapy compared to radical prostatectomy?
    At 5–10 years, focal therapy provides cancer control comparable to radical prostatectomy while preserving urinary and sexual function far better. A study in Nature found equivalent oncological outcomes over 8 years.

    Cancer Control (5–10 years):
    - Cancer-specific survival: 99–100% (FT) vs 95–98% (RP)
    - Metastasis-free survival: 95–98% for both
    - 7-year failure-free survival: 69% (FT), similar for RP

    Functional Outcomes:
    - Pad-free continence: 93–100% (FT) vs 60–85% (RP)
    - Erectile function preserved: 75–98% (FT) vs 13–67% (RP)

    The HEAT registry reports 100% metastasis-free survival and no cancer deaths at 7 years in 1,379 patients. Focal therapy can also be repeated, whereas radical surgery cannot.
    Are there ongoing clinical trials that I can join?
    Yes, several clinical trials are actively recruiting for focal therapy research. The FDA cleared NanoKnife for prostate ablation in 2024 based on PRESERVE trial data, reflecting ongoing global research.

    Current research areas include:
    - Registries comparing focal therapy technologies
    - Long-term outcome studies beyond 10 years
    - Trials for specific patient groups
    - Combination therapy approaches

    How to explore participation:
    1. Speak with your consultant during assessment
    2. Review eligibility criteria (often Gleason 6–7, localised disease)
    3. Search “focal therapy prostate” on ClinicalTrials.gov

    Consultants at The Focal Therapy Clinic, including Mr Tim Dudderidge, actively contribute to research such as the HEAT registry and multicentre studies.

    Contact us to discuss available trials.
    How is focal therapy monitored after treatment to ensure it is effective?
    Monitoring uses regular PSA tests and MRI imaging to confirm cancer removal and detect recurrence early.

    First Year:
    - PSA every 3 months
    - MRI at 12 months
    - Biopsy only if MRI or PSA raises concern

    Years 2–3:
    - PSA every 6 months
    - MRI only if clinically needed

    Long-term (Year 4+):
    - Annual PSA
    - Optional MRI at 3–5 years

    What we measure:
    - PSA drop of around 50–70%
    - MRI showing no residual disease
    - No new suspicious lesions

    The PI-FAB scoring system, developed by imaging specialists including Dr Clare Allen, standardises post-treatment MRI reporting. If recurrence occurs (5–10% of cases), options include repeat focal therapy or salvage treatments, with all future treatments kept open.

    Any questions?

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

    0207 036 8870

    info@thefocaltherapyclinic.co.uk

    Contact the team






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