PREVENT trial: Transperineal biopsy lowers risk of infection vs transrectal biopsy

Transperineal biopsy yielded a lower risk of infectious complications while maintaining a similar rate of prostate cancer detection compared with transrectal biopsy, according to final results from the PREVENT trial (NCT04843566), which were recently published in JAMA Oncology.¹

The rates of other complications were low and similar between both groups.

“While the potential advantages to the transperineal approach have been suggested, high-level category 1 evidence was limited,” explained senior author Edward M. Schaeffer, MD, PhD, the Harold Binstein Professor and Chief of Urology at Northwestern Medicine in Chicago, Illinois, in a news release on the findings.² “This study shows that transperineal prostate biopsy without antibiotic prophylaxis significantly is associated with a lower risk of infection compared to transrectal biopsy with targeted prophylaxis. Our data supports a transperineal approach to prostate biopsy as a new standard of care.”

Overall, data from the trial showed that in the intent-to-treat (ITT) population, no patients in the transperineal cohort experienced an infection, compared with 1.6% of patients (grade 2+; n = 6) in the transrectal cohort (difference, −1.6%; 95% CI, −3.5% to −0.3%; P = .02).

The rates of other complications were low and similar between both groups. Specifically, the rate of urinary retention was 0.3% (n = 1) in the transperineal arm vs 1.1% (n = 4) in the transrectal arm (difference, -0.8%; 95% CI, -2.5 to 0.6; P = .20). No patients in the transperineal cohort experienced bleeding, compared with 0.3% of patients (n = 1) in the transrectal cohort (difference, -0.3%; 95% CI, -1.5 to 0.8; P = .50).

High-grade cancer (Gleason grade 2 or higher) was detected in 55% of patients (n = 203) in the transperineal cohort compared with 52% of patients (n = 192) in the transrectal cohort (difference, 2.9%; 95% CI, −4.1% to 9.8%; P = .40). Gleason grade group 1 disease was detected across 15% of patients (n = 57) in the transperineal cohort vs 18% of patients (n = 68) in the transrectal cohort (difference, -3.1%; 95% CI, -8.6 to 2.4; P = .30).

In total, the prospective PREVENT trial enrolled 875 adult patients from February 2021 through March 2024 across 10 centers in the United States. Patients were eligible for enrollment if they had not received a prior prostate biopsy. Patients were excluded if they had acute prostatitis within the prior 6 months, a current non-urologic bacterial infection, or prior definitive therapy for prostate cancer.³

Those included in the trial were randomly assigned to undergo MRI-guided transperineal biopsy (n = 432) with no antibiotics or MRI-guided transrectal biopsy (n = 443) with the addition of targeted prophylaxis. Of those, 372 patients in the transperineal arm and 370 patients in the transrectal arm were included in the ITT analysis.

The primary outcome measure was infection, including uncomplicated and complicated genitourinary infection and urosepsis, which was tracked until 7 days following biopsy. Secondary outcome measures included the detection of high-grade cancer (Gleason grade group 2 or higher) and the occurrence of non-infectious complications.

The authors point out that these findings are inconsistent with those from the single-center ProBE-PC trial (NCT04081636), which found no difference in the rate of infection between transperineal and transrectal biopsy.⁴ The authors note that the difference in findings in PREVENT may be because the ProBE-PC trial may have captured infections that were not related to the biopsy. In PREVENT, infection was tracked until 7 days following biopsy and excluded patients with recent prostatitis, compared with ProBE-PC, which tracked infection until 30 days following biopsy and included patients with recent prostatitis.

Lead author Jim C. Hu, MD, the Ronald P. Lynch Professor of Urologic Oncology at Weill Cornell Medicine and the director of the LeFrak Center for Robotic Surgery at NewYork-Presbyterian/Weill Cornell Medical Center, concluded in a separate news release,⁵ “Transperineal biopsy should be the new standard of care for prostate biopsy. It was as effective as the traditional transrectal biopsy approach at detecting cancer, but without the risk of infection or the need for antibiotics.”

References

1. Hu JC, Assel M, Allaf ME, et al. Transperineal vs transrectal prostate biopsy—The PREVENT randomized clinical trial. JAMA Oncol. Published online September 19, 2024. Accessed September 20, 2024. doi:10.1001/jamaoncol.2024.4000

2. Northwestern Medicine study advocates for alternative biopsy approach for detecting prostate cancer. News release. Northwestern Medicine. September 19, 2024. Accessed September 20, 2024. https://news.nm.org/northwestern-medicine-study-advocates-for-alternative-biopsy-approach-for-detecting-prostate-cancer/

3. PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy (PREVENT). ClinicalTrials.gov. Last updated September 12, 2024. Accessed September 20, 2024. https://clinicaltrials.gov/study/NCT04843566

4. Mian BM, Feustel PJ, Aziz A, et al. Complications Following Transrectal and Transperineal Prostate Biopsy: Results of the ProBE-PC Randomized Clinical Trial. J Urol. 2024;211(2):205-213. doi:10.1097/JU.0000000000003788

5. New prostate biopsy technique lowers infection risk. News release. Weill Cornell Medicine. September 19, 2024. Accessed September 20, 2024. https://news.weill.cornell.edu/news/2024/09/new-prostate-biopsy-technique-lowers-infection-risk