Transperineal Versus Transrectal Magnetic Resonance Imaging-targeted and Systematic Prostate Biopsy to Prevent Infectious Complications: The PREVENT Randomized Trial.

The transrectal biopsy approach is traditionally used to detect prostate cancer. An alternative transperineal approach is historically performed under general anesthesia, but recent advances enable transperineal biopsy to be performed under local anesthesia. We sought to compare infectious complications of transperineal biopsy without antibiotic prophylaxis versus transrectal biopsy with targeted prophylaxis.

We assigned biopsy-naïve participants to undergo transperineal biopsy without antibiotic prophylaxis versus transrectal biopsy with targeted prophylaxis (rectal culture screening for fluoroquinolone-resistant bacteria and antibiotic targeting to culture and sensitivity results) through a multicenter, randomized trial. The primary outcome was post-biopsy infection captured by a prospective medical review and patient report on a 7-d survey. The secondary outcomes included cancer detection, noninfectious complications, and a numerical rating scale (0-10) for biopsy-related pain and discomfort during and 7-d after biopsy.

A total of 658 participants were randomized, with zero transperineal versus four (1.4%) transrectal biopsy infections (difference -1.4%; 95% confidence interval [CI] -3.2%, 0.3%; p = 0.059). The rates of other complications were very low and similar. Importantly, detection of clinically significant cancer was similar (53% transperineal vs 50% transrectal, adjusted difference 2.0%; 95% CI -6.0, 10). Participants in the transperineal arm experienced worse periprocedural pain (0.6 adjusted difference [0-10 scale], 95% CI 0.2, 0.9), but the effect was small and resolved by 7-d.

Office-based transperineal biopsy is tolerable, does not compromise cancer detection, and did not result in infectious complications. Transrectal biopsy with targeted prophylaxis achieved similar infection rates, but requires rectal cultures and careful attention to antibiotic selection and administration. Consideration of these factors and antibiotic stewardship should guide clinical decision-making.

In this multicenter randomized trial, we compare prostate biopsy infectious complications for the transperineal versus transrectal approach. The absence of infectious complications with transperineal biopsy without the use of preventative antibiotics is noteworthy, but not significantly different from transrectal biopsy with targeted antibiotic prophylaxis.

European urology. 2024 Jan 11 [Epub ahead of print]

Jim C Hu, Melissa Assel, Mohamad E Allaf, Behfar Ehdaie, Andrew J Vickers, Andrew J Cohen, Benjamin T Ristau, David A Green, Misop Han, Michael E Rezaee, Christian P Pavlovich, Jeffrey S Montgomery, Keith J Kowalczyk, Ashley E Ross, Shilajit D Kundu, Hiten D Patel, Gerald J Wang, John N Graham, Jonathan E Shoag, Ahmed Ghazi, Nirmish Singla, Michael A Gorin, Anthony J Schaeffer, Edward M Schaeffer

Brady Department of Urology, New York Presbyterian Weill Cornell Medicine Hospital, New York, NY, USA. Electronic address: ., Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA., James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Department of Surgery, Division of Urology, UConn Health, Farmington, CT, USA., Brady Department of Urology, New York Presbyterian Weill Cornell Medicine Queens, New York, NY, USA., Department of Urology, Michigan Medicine, Ann Arbor, MI, USA., Department of Urology, MedStar Georgetown University Hospital, Washington, DC, USA., Department of Urology, Northwestern Medicine, Northwestern University, Chicago, IL, USA., Brady Department of Urology, New York Presbyterian Weill Cornell Medicine Brooklyn, New York, NY, USA., Department of Urology, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH, USA., Department of Urologic Surgery, The Mount Sinai Hospital, Icahn School of Medicine, New York, NY, USA.