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.

Abstract

Long-term outcome data for focal therapy using high-intensity focused ultrasound (HIFU) or cryotherapy for nonmetastatic prostate cancer are needed. We report 10-yr cancer control outcomes. Patients with nonmetastatic prostate cancer who underwent primary focal HIFU or cryotherapy and had at least 6 mo follow-up were identified from the UK HIFU Evaluation and Assessment of Treatment (HEAT) and International Cryotherapy Evaluation (ICE) prospectively maintained registries. The intervention included up to two focal ablative sessions. The primary outcome was cancer-specific mortality. Secondary outcomes were all-cause mortality, metastasis, local retreatment, radical treatment, and androgen-deprivation therapy (ADT) use. A total of 3477 patients (HIFU: n = 2897; cryotherapy: n = 580) were included from 14 UK centres (2004-2024). A total of 48%, 23%, and 25% had European Association of Urology (EAU) 2025-version favourable intermediate-, unfavourable-intermediate-, and high-risk disease, respectively. Ten-yr cancer-specific mortality was 0.13% (95% confidence interval [CI] = 0.027-0.45%). Ten-yr all-cause mortality and metastases were 12% (95% CI = 8.8-15%) and 3.3% (95% CI = 2.1-4.9%), respectively. Ten-yr ADT use was 14% (95% CI = 11-17%). Ten-yr local retreatment and radical treatment were 33% (95% CI = 30-37%) and 30% (95% CI = 27-34%), respectively, on an intention-to-treat basis. In a post hoc per-protocol analysis, undertaken to estimate outcomes under stricter adherence to the two focal ablative session protocol, patients who underwent radical treatment despite being potentially eligible for a further focal ablative session were censored at the time of radical treatment; 10-yr local retreatment and radical treatment were 13% (95% CI = 11-16%) and 8.9% (95% CI = 6.9-11%), respectively. The observational study design is the main limitation. Focal therapy using up to two sessions of focal HIFU or cryotherapy could be considered as a first-line treatment for well-selected patients of nonmetastatic prostate cancer alongside radical treatment. Future research priorities should include the development of a dedicated prognostic risk calculator, further prospective assessment of focal therapy for high-risk disease, and improvements in the detection and management of locally recurrent disease.