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JU INSIGHT Complications Following Transrectal and Transperineal Prostate Biopsy: Results of the ProBE-PC Trial

By: Badar M. Mian, MD, Albany Medical Center, New York; Paul J. Feustel, PhD, Albany Medical Center, New York; Asef Aziz, MD, Albany Medical Center, New York; Ronald P. Kaufman Jr, MD, Albany Medical Center, New York; Adrien Bernstein, MD, Albany Medical Center, New York; Svetlana Avulova, MD, Albany Medical Center, New York; Hugh A.G. Fisher, MD, Albany Medical Center, New York | Posted on: 21 Feb 2024

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.

Study Need and Importance

Risk of infectious complications after transrectal prostate biopsy is reported to be on the rise. Transperineal prostate biopsy has been proposed as the superior alternative due to minimal risk of infection. However, the guidelines related to prostate biopsy procedure are conflicting. The existing data consist entirely of observational cohort analyses, with a distinct lack of randomized comparative studies. We conducted the first randomized controlled trial, with prespecified outcomes, to directly compare the infectious and noninfectious complications associated with these biopsy procedures.

What We Found

Among the 763 men randomized to either the transrectal or transperineal prostate biopsy, postbiopsy composite infectious complications occurred in 2.6% and 2.7% of men, respectively. No cases of sepsis were noted (Figure). Our definition of infectious complications was quite inclusive and incorporated “possible” infectious events. Utilizing a more stringent definition, as used in other studies (documented UTI, sepsis, antibiotics), the infectious complication rates in our study were 1.1% and 1.4% for transrectal and transperineal biopsy, respectively. All biopsy procedures were performed in the office, using local anesthesia, with 1-day antibiotic prophylaxis for transrectal procedures, and only occasional antibiotic prophylaxis for transperineal biopsy. Noninfectious complications rates (urinary retention, emergency visit, hospitalization) were 1.7% and 2.2% after transrectal and transperineal biopsies, respectively. All infectious and noninfectious complications were minor and/or self-limited.

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Figure. The risk of composite and individual infectious complications after transrectal and transperineal prostate biopsy procedures. ER indicates emergency room.

Limitations

The majority of the participants were White (92.6%), and the results may not be applicable to other ethnic groups. Our single-center design can limit generalizability to other settings, although our pragmatic design and multilocation recruitment can mitigate some of those concerns.

Interpretation for Patient Care

There was no difference in the risk of infectious complications after transrectal and transperineal prostate biopsy. Both procedures were associated with a low risk of minor complications.

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