Oncological outcomes of primary focal HIFU or cryotherapy (up to two sessions) for nonmetastatic prostate cancer were assessed in 3477 UK patients from the prospective HEAT and ICE registries (2004–2024), with follow-up to 10 years. Patients had EAU 2025 favourable intermediate- (48%), unfavourable intermediate- (23%), and high-risk disease (25%).
Ten-year cancer-specific mortality was just 0.13% (95% CI 0.027–0.45%). Ten-year metastasis was 3.3%, all-cause mortality 12%, and ADT use 14%. On intention-to-treat analysis, 10-yr local retreatment was 33% and radical treatment 30%; in a per-protocol analysis (censoring patients who went to radical treatment when still eligible for a further focal session), these fell to 13% and 8.9%, respectively.
Observational registry design limits causal inference and introduces selection bias. No randomized comparator arm (e.g., radical prostatectomy or radiotherapy) was included. The per-protocol analysis is post hoc and may underestimate real-world radical treatment rates.
Focal HIFU or cryotherapy yields very low 10-year cancer-specific mortality (<0.2%) and may be offered as a first-line option alongside radical treatment for well-selected patients with nonmetastatic prostate cancer. Clinicians should counsel patients that roughly one-third will need local retreatment or radical salvage over 10 years on an intention-to-treat basis, though stricter protocol adherence substantially reduces these rates.
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