PREVENT Trial Compares Transperineal And Transrectal Prostate Biopsy

Key Takeaways

• Post-biopsy infection was not observed after transperineal biopsy, while infections occurred after transrectal biopsy.
• High-grade prostate cancer detection was similar between the two biopsy approaches.
• Other complications were infrequent in both groups, and the authors said the transperineal approach allows exclusion of prophylactic antibiotics and may improve antibiotic stewardship.

In the PREVENT randomized clinical trial, patients with suspicion for prostate cancer had no infections after clinic-based transperineal biopsy, compared with 6 after transrectal biopsy. The randomized comparison paired transperineal biopsy without antibiotic prophylaxis with transrectal biopsy with targeted prophylaxis in a first-time biopsy population across 10 centers. High-grade cancer detection was similar between the biopsy routes.

The trial enrolled patients at 10 centers from February 2021 through March 2024 and focused on those undergoing a first prostate biopsy for suspected cancer. Clinic-based transperineal biopsy omitted antibiotic prophylaxis, while transrectal biopsy used targeted prophylaxis with rectal culture screening for fluoroquinolone-resistant bacteria. Among 875 randomized patients, 372 underwent biopsy in the transperineal group and 370 in the transrectal group. The primary outcome was post-biopsy infection, defined as uncomplicated or complicated genitourinary infection or urosepsis, assessed by 7-day survey and medical record review.

For the primary endpoint, the between-group difference in infection was -1.6%, with a 95% CI from -3.5% to -0.3% and P=.02. High-grade cancer, defined as Gleason grade group 2 or higher, was detected in 55% of the transperineal group and 52% of the transrectal group. That yielded a difference of 2.9%, with a 95% CI from -4.1% to 9.8% and P=.40. Infections differed between groups, while high-grade disease detection was similar.

Other complications were low and similar between groups, including urinary retention in 1 transperineal patient versus 4 transrectal patients and bleeding in 0 versus 1 patient. The authors said the transperineal approach allows exclusion of antibiotic prophylaxis and may improve antibiotic stewardship. They noted several limitations, including the focus on first-time biopsy, exclusion of randomized patients who did not undergo biopsy from the intent-to-treat analysis because they were not at risk, and use of targeted rather than augmented prophylaxis in the transrectal arm. Repeat-biopsy settings remain understudied.