Predicting 1-Year Trifecta Outcomes After High-Intensity Focused Ultrasound and Cryoablation for Low- and...

Objectives: Focal therapy (FT) is increasingly employed in selected patients with localized prostate cancer (PCa), aiming to balance oncologic control with preservation of urinary and sexual function. Among the available energy sources, prostate gland cryoablation (PGC) and high-intensity focused ultrasound (HIFU) are the most widely adopted techniques. However, comparative outcome data remain limited, and standardized composite endpoints are still lacking in this domain. Methods: We conducted a prospective, single-center study on 163 consecutive patients treated with FT, either HIFU (n = 49) or PGC (n = 114), for clinically localized PCa between 2019 and 2024. The primary aim was to compare baseline, perioperative, oncologic, and functional outcomes at 1-year follow-up. The secondary objective was to identify predictors of trifecta achievement, defined as: (1) absence of treatment failure; (2) urinary continence (no pads or one safety pad/day); and (3) recovery of erectile function comparable to baseline. Results: HIFU was associated with shorter operative time (p = 0.04) but required longer catheterization (p < 0.001). Compared with HIFU, primary whole-gland cryoablation (PGC) showed a higher overall complication rate (p < 0.001), mostly grade I-II events. Median follow-up was shorter for HIFU (12 vs. 23 months, p < 0.001). Further, 1-year treatment failure occurred in 8.1% of HIFU cases and 8.7% of PGC cases (p = 0.96), although failure-free survival was comparable between groups (p = 0.89). Functional outcomes were similar, with no significant differences in continence or potency recovery, and trifecta rates were 38.9% (HIFU) vs. 37.4% (PGC; p = 0.355). On multivariable analysis, hypertension, lower PSA, higher baseline erectile function, and unilateral ablation independently predicted trifecta achievement. Conclusions: In this prospective comparison between HIFU and PGC, we observed similar trifecta achievement rates, with no significant differences in continence or erectile function recovery at 1 year. Although treatment failure was slightly more frequent after HIFU, overall outcomes support the functional safety and oncologic feasibility of both approaches in selected patients. These findings suggest that adopting a standardized composite endpoint may be clinically useful, even if further refinement and validation are still needed to capture the specific goals and nuances of focal therapy.