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

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.

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.

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.

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.