BACKGROUND AND OBJECTIVE: The benefits of the detection of clinically significant prostate cancer (csPCa) and safety of magnetic resonance imaging (MRI)-targeted transperineal (TP) prostate biopsy (TP-Tbx) versus transrectal (TR) approaches are still a matter of debate. This review aims to compare the efficacy and safety of TP-Tbx and MRI-targeted TR biopsy (TR-Tbx). METHODS: A systematic literature search was performed in PubMed/Medline, Scopus, and Web of Science to identify records of prospective randomized controlled trials (RCTs) comparing TP-Tbx and TR-Tbx published until May 2024. The primary outcomes included detection rates of csPCa (International Society of Urological Pathology [ISUP] ≥2) and rates of complications. KEY FINDINGS AND LIMITATIONS: Three RCTs (PREVENT, ProBE-PC, and PERFECT) met the inclusion criteria. The TR technique was commonly administered with antibiotic prophylaxis to mitigate infection risks or after a rectal swab. No difference was found between TP-Tbx and TR-Tbx in terms of either csPCa (odds ratio [OR] 0.9, 95% confidence interval [CI]: 0.7-1.1) or ISUP 1 prostate cancer (PCa; OR 1.1, 95% CI: 0.8-1.4) detection. Postprocedural infection (OR 0.8, 95% CI: 0.4-1.8), sepsis (OR 0.6, 95% CI: 0.1-4.5), and urinary retention rates (OR 0.5, 95% CI: 0.1-1.6) were similar. Pain during the TP approach was slightly higher than during the TR approach, but after 7 d of follow-up, the differences between the two approaches were minimal. Variations in biopsy numbers per patient, patient selection, use of 5-alpha reductase inhibitors, needle sizes, TP techniques, and pain scores (reported in only one RCT), along with the multicenter nature of RCTs, limit the study. CONCLUSIONS AND CLINICAL IMPLICATIONS: TP-Tbx and TR-Tbx show similar results in detecting PCa, with comparable rates of infections, urinary retention, and effectiveness in managing biopsy-associated pain. TP-Tbx can safely omit antibiotics without increasing infection risk, unlike TR-Tbx. The tendency to exclude from practice TR-Tbx with prophylactic antibiotics due to infection concerns could be moderated; however, the directionality of some key outcomes, as infections and sepsis, favor the TP approach despite a lack of statistical significance. PATIENT SUMMARY: There were no significant differences in the prostate biopsy approaches (transperineal [TP] vs transrectal [TR]) for prostate cancer detection and complications. However, the MRI-targeted TP prostate biopsy approach may be advantageous as it can be performed safely without antibiotics, potentially reducing antibiotic resistance.

Department of Surgery Oncology and Gastroenterology Urology Clinic University of Padua Padua Italy

Department of Surgery Oncology and Gastroenterology Urology Clinic University of Padua Padua Italy; Department of Medicine DIMED University of Padua Padua Italy

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 Comprehensive Cancer Center Medical University of Vienna Vienna Austria; Department of Urology Medical University of Silesia Zabrze Poland

Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria; Department of Urology Semmelweis University Budapest Hungary

Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria; Department of Urology Semmelweis University Budapest Hungary; Institute for Urology and Reproductive Health Sechenov University Moscow Russia; Department of Urology University of Texas Southwestern Medical Center Dallas TX USA; Department of Urology Weill Cornell Medical College New York NY USA; Department of Urology 2nd Faculty of Medicine Charles University Prague Czechia; Division of Urology Department of Special Surgery The University of Jordan Amman Jordan; Karl Landsteiner Institute of Urology and Andrology Vienna Austria; Research Center for Evidence Medicine Urology Department Tabriz University of Medical Sciences Tabriz Iran

Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria; Department of Urology The Jikei University School of Medicine Tokyo Japan

Department of Urology Mayo Clinic Rochester MN USA

La Croix du Sud Hospital Quint Fonsegrives France

Unit of Urology Division of Oncology URI IRCCS Ospedale San Raffaele Milan Italy

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