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.
European urology oncology. 2025 Apr 17 [Epub ahead of print]
Aleksander Ślusarczyk, Adam Gurwin, Anna Barnaś, Hamza Ismail, Marcin Miszczyk, Piotr Zapała, Mikołaj Przydacz, Wojciech Krajewski, Andrzej Antczak, Marcin Życzkowski, Łukasz Nyk, Giancarlo Marra, Juan G Rivas, Veeru Kasivisvanathan, Giorgio Gandaglia, Morgan Rouprêt, Guillaume Ploussard, Shahrokh F Shariat, Bartosz Małkiewicz, Piotr Radziszewski, Tomasz Drewa, Roman Sosnowski, Paweł Rajwa, Section of Urologic Oncology of Polish Urological Association
Department of General, Oncological and Functional Urology, Medical University of Warsaw, Warsaw, Poland., University Center of Excellence in Urology, Department of Minimally Invasive and Robotic Urology, Wroclaw Medical University, Wroclaw, Poland., Department and Clinic of Urology and Urologic Oncology, Poznan University of Medical Science, Poznan, Poland., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Collegium Medicum-Faculty of Medicine, WSB University, Dąbrowa Górnicza, Poland., Department of Urology, Jagiellonian University Medical College, Kraków, Poland., Clinic of Urology, Institute of Medical Sciences, University of Opole, Opole, Poland., Second Department of Urology, Centre of Postgraduate Medical Education, Warsaw, Poland., Department of Urology, San Giovanni Battista Hospital, Città della Salute e della Scienza, Turin, Italy; University of Turin, Turin, Italy., Department of Urology, Clinico San Carlos Hospital, Madrid, Spain., Division of Surgery and Interventional Science, University College London, London, UK., Division of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy., Urology, GRC 5 Predictive Onco-Uro, AP-HP, Pitie-Salpetriere Hospital, Sorbonne University, Paris, France., Department of Urology, La Croix du Sud Hospital, Quint Fonsegrives, France., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Division of Urology, Department of Special Surgery, The University of Jordan, Amman, Jordan; Karl Landsteiner Institute of Urology and Andrology, Vienna, Austria; Department of Urology, Weill Cornell Medical College, New York, NY, USA; Department of Urology, University of Texas Southwestern, Dallas, TX, USA; Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czech Republic; Department of Urology, Semmelweis University, Budapest, Hungary., Department of General and Oncologic Urology, Antoni Jurasz University Hospital No. 1, Bydgoszcz, Poland., Department of Urology and Oncological Urology, Warmian-Masurian Cancer Center, Olsztyn, Poland., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Second Department of Urology, Centre of Postgraduate Medical Education, Warsaw, Poland; Division of Surgery and Interventional Science, University College London, London, UK. Electronic address: .