Large registry study reports durable 10-year outcomes with focal therapy for prostate cancer

Ten-year outcomes from a large UK registry analysis suggest that focal therapy with high-intensity focused ultrasound (HIFU) or cryotherapy may provide durable cancer control in carefully selected patients with nonmetastatic prostate cancer, with prostate cancer-specific mortality remaining below 1% over a decade of follow-up.¹

The observational study, published in European Urology, included nearly 3500 patients treated across 14 UK centers and represents the largest long-term analysis of focal therapy reported to date. According to the authors, the results suggest that focal therapy may be considered as a first-line treatment option for well-selected patients alongside radical treatment.

"The results of our study are really encouraging,” said study author Alexander Light, MBBS, BSc (Hons), MRCS, an NIHR Doctoral Fellow at Imperial College London and urology registrar at Imperial College Healthcare NHS Trust, in a news release on the results.² “Ten years on, only 2 men in the study had died from their prostate cancer and many men have benefitted from the treatment, including men with more aggressive disease who would traditionally have been told focal therapy wasn't an option for them."

Related: The UroOnc Minute: Salvage Focal Therapy for Radiorecurrent Prostate Cancer, with Alexander Light, MBBS

Registry analysis reports durable long-term outcomes

For the study, investigators analyzed data from the UK HIFU Evaluation and Assessment of Treatment (HEAT) registry and the International Cryotherapy Evaluation (ICE) registry. Eligible patients underwent primary focal HIFU or focal cryotherapy between 2004 and 2024 and had at least 6 months of follow-up.

The study included 3477 patients, of whom 2897 received HIFU and 580 underwent cryotherapy. According to European Association of Urology (EAU) 2025 risk classifications, 48% had favorable intermediate-risk disease, 23% had unfavorable intermediate-risk disease, and 25% had high-risk disease.

The primary end point was prostate cancer-specific mortality. Secondary end points included all-cause mortality, metastatic progression, local retreatment, radical treatment, and androgen deprivation therapy (ADT) use.

At 10 years, prostate cancer-specific mortality was 0.13% (95% CI, 0.027% to 0.45%). All-cause mortality reached 12% (95% CI, 8.8% to 15%), whereas metastatic disease developed in 3.3% of patients (95% CI, 2.1% to 4.9%). The cumulative incidence of ADT use at 10 years was 14% (95% CI, 11% to 17%).

Using an intention-to-treat analysis, investigators reported cumulative 10-year rates of 33% (95% CI, 30% to 37%) for local retreatment and 30% (95% CI, 27% to 34%) for radical treatment. However, in a post hoc per-protocol analysis that censored patients who underwent radical treatment despite remaining eligible for an additional focal treatment session, 10-year local retreatment was 13% (95% CI, 11% to 16%), whereas radical treatment decreased to 8.9% (95% CI, 6.9% to 11%).

"Our study now gives clinicians and patients the long-term evidence they have been waiting for,” said joint senior author Taimur Shah, MBBS, BSc (Hons), FRCS (Urol), PhD, consultant urologist and associate professor at Imperial College London and Imperial College Healthcare NHS Trust, in the news release.² “We hope these results will help update the main NICE clinical guidelines so that focal therapy is routinely offered as a first-line choice to men. Men who would like to know whether it might be right for them can ask their urologist about referral to a specialist center that performs these treatments."

Clinical context

The findings also come as the UK government has committed £2.8 million in capital funding to expand focal therapy alongside the ongoing TRANSFORM trial, with the aim of increasing access to the treatment while generating additional prospective evidence to inform future screening and treatment strategies.

"This is the largest and longest running study demonstrating that focal therapy delivers excellent long-term cancer control across a broad range of patients,” added joint senior author Hashim Ahmed, PhD, BM, BCh, consultant urologist and chair of urology at Imperial College London and Imperial College Healthcare NHS Trust, who also leads the TRANSFORM screening study, in the news release.² “It makes a compelling case for more centers to offer this treatment, and I am pleased to see the government make a firm commitment of capital funding to support it. Right now, only about 1000 men per year have the treatment, when up to 15,000 men could—and are either not told about it, or do not have local access."

Related: The UroOnc Minute: Focal Therapy for Prostate Cancer, With Hashim U. Ahmed, BM BCh (Oxon)

The investigators identified several priorities for future research, including development of a dedicated prognostic risk calculator, improved approaches for detecting local recurrence, and prospective evaluation of focal therapy in patients with high-risk localized disease.

REFERENCES

1. Light A, Peters M, Gopalakrishnan A, et al. Oncological outcomes following focal HIFU and cryotherapy for treatment of nonmetastatic prostate cancer in the United Kingdom: An updated analysis of 3477 patients from the prospective HEAT and ICE registries. Eur Urol. 2026 Jul 10:S0302-2838(26)02169-X. doi:10.1016/j.eururo.2026.05.007

2. New study shows focal therapy effectively treats prostate cancer, keeping patients cancer free ten years after treatment. News release. NHS Imperial College Healthcare. July 17, 2026. Accessed July 30, 2026. https://www.imperial.nhs.uk/about-us/news/new-study-shows-focal-therapy-treats-prostate-cancer