Outcomes of Focal Therapy for Localized Prostate Cancer: A Systematic Review and Meta-analysis of Prospective Studies

Background and objective: Focal therapies (FTs) for localized prostate cancer (PCa) are recommended only within prospective registries or clinical trials. In this systematic review and meta-analysis, we aimed to synthesize data from prospective trials evaluating the efficacy and safety of FTs in patients with clinically localized PCa. Methods: Systematic searches of the PubMed, Scopus, and Web of Science databases identified prospective studies reporting oncological outcomes of FTs in treatment-naïve, clinically localized PCa patients. The primary endpoint was biopsy-proven clinically significant PCa (csPCa; International Society of Urological Pathology grade group ≥2) recurrence-free survival (csPCa RFS). The secondary endpoints included RFS, radical/systemic treatment-free survival, and adverse event (AE) rates. Key findings and limitations: Fifty studies including 4615 patients treated with FTs were analyzed; of these 50 studies, 19 were on predominantly intermediate-risk (n = 2800), 16 on mixed low-/intermediate-risk (n = 990), and 15 on low-risk (n = 825) patients. Estimates of 12- and 24-mo csPCa RFS rates were 86% (95% confidence interval [CI] 82-89%) and 81% (95% CI: 74-86%), respectively. In the intermediate-risk subgroup, the 12-mo csPCa RFS rate was 79% (95% CI: 74-83%). Five-year radical and systemic treatment-free survival was 82% (95% CI: 75-88%). The pooled incidence of grade ≥3 AEs was 3% (95% CI: 2-5%). Pad-requiring urinary incontinence increased by 3% (95% CI: 0-6%), with 11% of patients developing new erectile dysfunction (95% CI: 4-18%). The median follow-up of 21 mo (interquartile range 12-34) and the use of surrogate endpoints constitute the major limitations. Conclusions and clinical implications: The primarily short-term data from prospective studies of FT in clinically localized PCa demonstrate moderate to high cancer control with a favorable safety profile.