Ten-Year Oncological Evidence in Focal Therapy: HEAT and ICE Registry Analysis of 3,477 Patients Published in European Urology

KEY FINDINGS

• Cohort size: 3,477 patients (2,897 focal HIFU, 580 focal cryotherapy); 14 UK centres, 2004-2024. The largest long-term analysis of focal therapy to date.
• Prostate cancer-specific mortality: 0.13% at 10 years (95% CI 0.027-0.45) - only 2 of 3,477 patients died of prostate cancer.
• Metastatic progression: 3.3% at 10 years (95% CI 2.1-4.9; 42 events).
• Risk distribution is not as low as assumed: 23% of patients were in the unfavourable intermediate-risk and 25% in the high-risk group (EAU 2025 classification).
• Retreatment: In the intention-to-treat (ITT) analysis, 10-year local retreatment was 33% and conversion to radical treatment 30%; in the per-protocol analysis these were 13% and 8.9% respectively.
• ADT use: The 10-year cumulative incidence of androgen deprivation therapy was 14%.

Clinical Context: The Evidence Gap in Focal Therapy

In localized prostate cancer, radical prostatectomy and radiotherapy are standard treatments whose oncological efficacy has been established by long-term randomized data. However, both approaches carry outcomes that may permanently affect quality of life, such as urinary incontinence, erectile dysfunction and bowel toxicity. With the spread of multiparametric MRI and targeted biopsy, focal therapy - which targets the dominant focus (index lesion) of the tumour within the prostate while sparing healthy tissue - has attracted rapid interest over the past decade.

The fundamental obstacle facing focal therapy, however, has been the absence of robust evidence on long-term oncological safety. Guidelines have therefore largely positioned focal therapy within the context of clinical research or selected centres. This analysis published in European Urology targets precisely that evidence gap.

"The results of our study are highly encouraging. At the end of ten years only two patients in the study had died of prostate cancer, and a large number of patients benefited from this treatment, including men with more aggressive disease who have traditionally been told that focal therapy is not appropriate for them." - Alexander Light, MBBS, BSc (Hons), MRCS - NIHR Doctoral Research Fellow, Imperial College London

Study Design

This observational analysis draws on two prospective registries mandated at national level in the United Kingdom: HEAT (UK HIFU Evaluation and Assessment of Treatment) - the focal high-intensity focused ultrasound registry, and ICE (International Cryotherapy Evaluation) - the focal cryotherapy registry. The analysis included patients with non-metastatic prostate cancer who underwent primary focal HIFU or focal cryotherapy between 2004 and 2024 and had at least 6 months of follow-up.

Key Results

What the ITT versus per-protocol difference means: The clear difference between the two analyses should be interpreted carefully from a methodological standpoint. In the post-hoc per-protocol analysis, patients who were directed to radical treatment even though they were still eligible for an additional focal treatment session were censored. The per-protocol figures reflect the outcomes expected "when the focal therapy strategy is applied in full (as up to two sessions)", while the ITT figures reflect outcomes observed in the real world, shaped by patient preference, centre policy and clinical decisions. Sharing both sets of figures with the patient during counselling is important for realistic expectation management.

Implications for Clinical Practice

1. The oncological safety threshold appears to have been met

A 10-year cancer-specific mortality remaining at 0.13% indicates that focal therapy may be an oncologically safe strategy in a selected patient population. This value can be assessed on the same plane as long-term outcomes reported in active surveillance and radical treatment series. However, in the absence of randomized comparison, no claim of direct superiority can be drawn from these data.

2. Could patient selection expand?

It is notable that around half of the cohort was in the unfavourable intermediate-risk or high-risk group. Classically, focal therapy has been reserved for low-volume, favourable intermediate-risk disease. These data suggest that a focal approach may also be considered in well-selected high-risk cases. Even so, these subgroup analyses are hypothesis-generating and require prospective validation.

3. The reality of retreatment must be discussed transparently

The fact that in the ITT analysis one third of patients underwent local retreatment and 30% received radical treatment within 10 years shows that focal therapy should not be presented as a "one-off definitive solution". In most patients, focal therapy should be positioned as a treatment strategy - a roadmap that can be repeated when needed and that does not close off salvage options.

4. Centre experience and infrastructure are decisive

The results were obtained from centres with MRI-targeted diagnosis, an experienced imaging team, a standardised follow-up protocol and a biopsy strategy capable of detecting recurrence. The spread of focal therapy depends less on the technology itself than on reproducing this multidisciplinary infrastructure.

5. The health policy dimension

In parallel with the ongoing TRANSFORM screening study, the UK government has committed 2.8 million pounds of investment to expand focal therapy capacity. The investigators note that approximately 1,000 men currently receive this treatment each year, whereas up to 15,000 patients could be candidates.

Limitations

The observational, single-arm design of the study does not allow direct comparison with radical prostatectomy or radiotherapy. Selection bias in registry data, heterogeneity between centres and the changing standards of diagnosis and imaging over a period as broad as 2004-2024 are important constraints. In addition, follow-up protocols for detecting recurrence may differ between centres, which may affect retreatment rates. The investigators list the development of a prognostic risk calculator specific to focal therapy, the definition of better methods for detecting local recurrence and prospective evaluation in high-risk localized disease as priority research topics.

Conclusion

This updated analysis of the HEAT and ICE registries provides the long-awaited long-term oncological evidence on focal therapy. With a 10-year prostate cancer-specific mortality of 0.13% and a metastasis incidence of 3.3% in 3,477 patients, the data support the case that focal HIFU or cryotherapy can be discussed as a first-line option alongside radical treatment in appropriately selected patients.

Nevertheless, focal therapy should be positioned less as a substitute for radical treatment than as an option that broadens the treatment spectrum and offers the patient a more nuanced balance between function and oncological control. Correct patient selection, an experienced centre, rigorous follow-up and transparent patient information are indispensable components of this approach.

References

• 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. 10 July 2026. doi:10.1016/j.eururo.2026.05.007 - sciencedirect.com
• Clarke H. Large registry study reports durable 10-year outcomes with focal therapy for prostate cancer. Urology Times. 30 July 2026. - urologytimes.com
• New study shows focal therapy effectively treats prostate cancer, keeping patients cancer free ten years after treatment. Imperial College Healthcare NHS Trust. 17 July 2026. - imperial.nhs.uk
• Focal HIFU/cryotherapy show durable 10-year control in prostate cancer. CancerNetwork. 23 July 2026. - cancernetwork.com
• Focal therapy shows favorable long-term outcomes in prostate cancer. Medscape. July 2026. - medscape.com
• Expert reaction to study looking at focal therapy for prostate cancer. Science Media Centre. July 2026. - sciencemediacentre.org