Commentary
Video
Author(s):
“What we found was that the rate of complications due to infection were 2.6% with the transrectal approach, and 2.7% with the transperineal,” says Badar M. Mian, MD.
In this video, Badar M. Mian, MD, describes the background and key findings from the study, “Complications Following Transrectal and Transperineal Prostate Biopsy: Results of the ProBE-PC Randomized Clinical Trial,” for which he served as the lead author. Mian is a professor of surgery in the division of urology at Albany Medical College in Albany, New York.
Video Transcript:
Could you describe the background for the ProBE-PC trial?
The inception was based on this open question of whether one biopsy procedure, transrectal compared to transperineal, was different, better, or worse. There had been fairly rapid uptake of transperineal prostate biopsy, but the studies were lacking. We didn't have any randomized controlled trials. It was trendy. So, we were part of the trend; we started a program, just like many other people, thinking that [transperineal] might be better. There's some advantage to it. We started the program, but the question was still open [on] whether there is a clinically meaningful difference amongst the procedures, especially as relates to the main question that the transperineal biopsy is supposed to answer, which is a difference in infectious complications. We designed the trial to answer that question.
What were the key findings from this study?
We defined infectious complications a bit loosely so that we can capture even the minor complications that are clinically meaningful. The major complications we wanted to look at were sepsis. But mostly it was any kind of infection, whether it's minor or major, somebody with suspected infection who received antibiotics will be a clinically meaningful end point. What we found was that the rate of complications due to infection were 2.6% with the transrectal approach, and 2.7% with the transperineal. So, we did not find any difference. That was a bit surprising; we were expecting to find a difference, because [among] experts in the field, the impression was that there should be a difference. We didn't find a difference, so that was interesting and surprising. If we were to define infection more tightly, [with] more stringent criteria, it still didn't show a difference. The complications, such as fever, UTI, that are documented [with a] more robust clinical definition of infection. That rate was 1.4% with transperineal and 1.7% with transrectal. Again, no clinically significant difference, or even statistically significant difference was noted. These findings were very interesting and gave the entire field a pause to stop and rethink our impression.
This transcription has been edited for clarity.