Howard Wolinsky

19 September 2024 – Medscape.

Researchers have concluded that transperineal prostate (TP) biopsies should be standard of care because no infections were found among those who received this newer intervention, according to a study published on Thursday in JAMA Oncology.

The findings from the multicenter, randomized trial add to an ongoing debate in the United States over whether the TP biopsy is safer and detects more cancer than the traditional transrectal (TR) prostate biopsy.

The new study shows the two approaches are in a dead heat for diagnosing prostate cancer, but none of the participants who received TP developed infections while 1.6% of the TR group did. The TP method involves passing a needle through the perineum. 

"Our study shows a very low 0% infection risk, without the need for preventative antibiotics, which can potentially save lives," said Jim Hu, MD, MPH, urologic oncologist at NewYork-Presbyterian and Weill Cornell Medicine in New York City and lead author of the study. Weill Cornell was one of 10 centers involved in the PREVENT trial.

Six infections were observed in the TR group (between-group difference, −1.6; 95% CI, −3.5 to −0.3; P = .02). Most infections were mild and resolved without complication, said study author Edward Schaeffer, MD, PhD, chair of the Department of Urology at the Feinberg School of Medicine at Northwestern University in Chicago, Illinois.

Hu noted that studies typically report infection rates of 5% to 7% in patients undergoing TR biopsies. Patients in the TR group in the current study received targeted prophylaxis with rectal culture screening for fluoroquinolone-resistant bacteria.

"We believe this is why our transrectal biopsy infection risk is much lower than other studies," he said.

The researchers said TP should be standard of care, in part, because the method enables antibiotic stewardship. 

Current guidelines by the American Urological Association (AUA) and National Comprehensive Cancer Network (NCCN) give equal standing to TP and TR biopsies, whereas the European Association of Urologists favors TP biopsies. An NCCN spokeswoman said the organization had no comment.

An AUA spokeswoman said its guidelines are scheduled for review in 2025 and will be amended if sufficient evidence exists.

Over 3 years ending in March 2024 at 10 centers, patients with suspicion of prostate cancer were randomized to TP biopsy without antibiotic pretreatment (N = 372) or TR biopsy with antibiotics (N = 370).

Sepsis was not detected in either group. Infections in the TR group were mainly urinary tract infections, Hu told Medscape Medical News. 

Badar Mian, MD, professor of surgery at Albany Medical College, New York, and principal investigator of the first single-center randomized trial of TP versus TR, said his study included high-risk patients and also found no difference in infectious or noninfectious complications.

"The rate of infections in all of the randomized clinical trials is low and the infections are typically mild; this should allay the public's concerns about prostate biopsy-related infections," Mian said.

Cancer detection rates were similar in both groups. High-grade cancer was found in 55% of TP biopsies and 52% of TR biopsies (between-group difference, 2.9; 95% CI, −4.1 to 9.8; P = .40).

Richard Szabo, MD, a clinical professor at the University of California, Irvine, who has conducted safety studies on prostate biopsies, said TP biopsies help urologists detect clinically significant prostate cancer anteriorly and at the apex of the gland, where the transrectal approach can miss some cancer.

Schaeffer offers his patients TP but the procedure has not yet been widely adopted nationwide.

"The only way to move the needle on this issue is by getting laypeople involved," Szabo said. "They need to demand transperineal biopsies or just refuse transrectal biopsies."

The study authors have reported receiving personal fees, royalties, and grants, and having stock options in entities including Arctic Partners, OPKO, CIVCO Medical Instruments, Bristol Myers Squibb Foundation, and ForTec Medical, among others. Schaeffer is chair of the NCCN prostate panel. 

Howard Wolinsky is a Chicago-based medical writer. He writes the Substack blog TheActiveSurveillor.com