Transperineal prostate biopsies reduce infection, should be a ‘gold standard’
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Key takeaways:
- Transperineal prostate cancer biopsies did not cause any infections in a randomized trial.
- U.S. and European guidelines conflict about whether to use a transperineal or transrectal approach.
A transperineal approach to prostate cancer biopsies without the need for preventive antibiotics could eliminate risk for infection, according to results of a randomized trial.
No men who underwent transperineal biopsy developed an infection in the study, and transrectal biopsies still caused infections despite use of targeted antibiotic prophylaxis.
“Our study shows that transperineal biopsy has a lower infection rate than the most rigorous approach to prevent infection with transrectal biopsies,” Jim C. Hu, MD, MPH, urologic oncologist, vice chair of clinical research, chair of quality and patient safety, and the course director for urology grand rounds at Weill Cornell Medicine, told Healio.
“Transrectal biopsy has been the gold standard approach in the U.S., but transperineal biopsy should be the new standard of approach,” he added. “The issue is one of implementation.”
Background
Approximately 1.4 million prostate cancer diagnoses are made annually around the world and more than 3 million biopsies are conducted, according to study background.
Clinicians primarily perform transrectal biopsies; however, previous studies showed between 5% and 7% of men who undergo one develop an infection, and 1% to 3% of them require hospitalization, Hu said.
In most cases, infections developed because the biopsy needle passed through the rectum, which is contaminated despite use of enemas to reduce bacteria and antibiotics to prevent infection.
Transperineal biopsies have been conducted for about 2 decades, but they originally were performed under general anesthesia because the needle must go through the skin.
“[Conventional thinking] was that it would be too painful, and it couldn’t be tolerated in the office setting,” Hu said. “There was also this thinking that by going through the skin and through the pelvic floor muscles, there was a greater risk for urinary retention, or it would contribute to the inability to urinate after the biopsy.”
However, in the past several years, interest has grown in the procedure due to a pair of advances.
“There was a description of how to numb things up [locally] so that it would be less painful,” Hu said. “Second, the majority of transperineal biopsy enthusiast urologists [started using] an innovative, disposable device, which basically enables the attachment of a trocar to the ultrasound probe. That allowed a puncture through the skin to be visualized on the ultrasound in a very easy, coordinated way.”
Methods and results
Hu and colleagues conducted a 10-center study to investigate infection risk with transperineal biopsy vs. transrectal biopsy for men with suspicion for prostate cancer.
The transperineal cohort included 372 men and the transrectal group included 370 men.
The transrectal group received screening prior to biopsy to determine if they had a resistance to fluoroquinolone, the most common antibiotic used to prevent infection.
Traditionally, more than 50% of hospitalizations due to infection result from a fluoroquinolone resistance, Hu said. In the trial, individuals who had resistance received a different antibiotic.
Infection rate for both arms served as the primary endpoint.
Results showed no infections in the transperineal cohort vs. a 1.6% infection rate in the transrectal cohort (P = .02).
The rate of cancers found between transperineal and transrectal biopsies also appeared comparable (55% vs. 52%).
Men who underwent transperineal biopsy reported similar pain scores as those who underwent transrectal biopsy (3.6 vs. 3 on a 0-10 numerical rating scale).
“For men with first-time biopsy, I’ve stopped doing transrectal biopsies because I believe in our findings,” Hu said.
Conflicting guidelines
In 2019, Roar Gulbrandsen, a 68-year-old man from Norway, died because he developed an infection resulting from a transrectal biopsy. This spurred Norway to stop conducting transrectal biopsies, Hu said.
In 2021, the European Association of Urology recommended transperineal biopsies in its guidelines.
“The available evidence demonstrates that the transrectal approach should be abandoned in favor of the transperineal approach despite any possible logistical challenges,” the guidelines read.
However, the study Hu led is the first trial to demonstrate that transperineal biopsy significantly lowers infections.
The American Urological Association recommends either approach.
Earlier this year, Badar M. Mian, MD, urologic surgeon at Albany Medical Center, and colleagues published results of the Prostate Biopsy Efficacy and Complications randomized clinical trial in The Journal of Urology. The findings showed no differences in cancer detection or infection rate.
“There are significant differences in how the studies were conducted,” Hu said. “In [the study by Mian and colleagues] — and, mind you, both of our studies overlapped a little bit with COVID — if a patient called the doctor’s office because they felt like they had a fever or subjective fever or chills, they were considered to have an infection in the trial by Mian and colleagues. We required that they came in, got a urine culture — a laboratory value that was consistent with having an infection. Our definition of infection was much more rigorous.”
The conflicting results pose a barrier to transperineal biopsies becoming more common in the United States.
The National Institute for Health Research-funded TRANSLATE study in the United Kingdom aims to enroll more than 1,000 men to evaluate the primary outcome of cancer detection and infection rates secondarily, with the goal of determining which method is superior.
Hu and colleagues are evaluating men undergoing repeat biopsy through a Patient Centered Outcomes Research Institute randomized trial, as well.
“It takes two randomized control trials — two positive or significant findings — that show something’s better to change medical practice,” Hu said.
Other obstacles to further implementation of transperineal biopsies exist, too. These include reimbursement costs and comfort with the procedure. Availability also is a factor, and Hu noted less than 10% of practices nationally perform it.
“When you just start doing a new procedure and the patients are awake, you’re sweating bullets,” Hu said. “You’re doing this a new way. That learning curve at least to get comfortable and do it well is at least 30 to 40 cases.”
Transperineal biopsies the ‘future’
Though the transperineal vs. transrectal biopsy debate continues, Hu said the study findings from his group also should encourage clinicians to evaluate fluoroquinolone resistance if they continue to perform transrectal procedures.
Fluoroquinolone resistance is more common in certain areas of the country, including the Southeast, Hu said.
“There are a few more steps in that workflow [for targeted prophylaxis],” Hu said. “Doing the prostate exam, sending the rectal swab kit off to the lab, checking the computer again the next day, and, if there’s resistance, switching the antibiotic. A lot of people just don’t want to take those three additional steps. They take their best guess at prescribing multiple antibiotics, which may contribute to more resistance.”
Hu and colleagues found only 1% of patients on Medicare get a rectal swab sent.
Ultimately, the goal is to eliminate infections, and transperineal biopsies are the “future” of that end, Hu said.
“Once in a while, when I did transrectal biopsies, I’d get those calls in the evening — somebody would be going to the emergency room with a high fever [or] chills,” Hu said. “I’d be worried about them. That has stopped. I just don’t get those with transperineal biopsy.”
References:
- Early Detection of Prostate Cancer: AUA/SUO Guideline (2023). Available at https://www.auanet.org/guidelines-and-quality/guidelines/early-detection-of-prostate-cancer-guidelines. Accessed Oct. 15, 2024.
- End transrectal prostate biopsy in the U.S. Available at https://www.parsemus.org/2023/03/act-now-to-end-transrectal-prostate-biopsy-in-the-u-s/. Published March 20, 2023. Accessed Oct. 15, 2024.
- European Association of Urology; Guidelines; Prostate Cancer; Diagnostic Evaluation. Available at https://uroweb.org/guidelines/prostate-cancer/chapter/diagnostic-evaluation. Accessed Oct. 15, 2024.
- Hu JC, et al. JAMA Oncol. 2024;doi:10.1001/jamaoncol.2024.4000.
- Mian BM, et al. J Urol. 2024;doi:10.1097/JU.0000000000004081.
For more information:
Jim C. Hu, MD, MPH, can be reached at jch9011@med.cornell.edu.
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