Dr. Hu on future studies of transrectal vs transperineal prostate biopsy

In this video, Jim C. Hu, MD, MPH, shares secondary outcomes and future work based on the study, “Transperineal Versus Transrectal Magnetic Resonance Imaging–targeted and Systematic Prostate Biopsy to Prevent Infectious Complications: The PREVENT Randomized Trial.” Hu is a professor of urology at Weill Cornell Medicine / NewYork-Presbyterian Hospital in New York, New York.

Video Transcript:

In addition to expanding continued enrollment for first time biopsy, and I anticipate we'll hit that that enrollment target within the next 6 to 8 months, we'll do a re-analysis and see if there's statistical significance. We're also continuing to examine whether or not there's a difference in cancer detection rate, which I should mention was similar. That is, when we looked at detection of clinically significant prostate cancer, defined as grade group 2 or higher, we found that in the transperineal arm it was 53%, and in the transrectal arm it was 50%. So, those were very similar and didn't differ.

I should also note that [with] the transperineal biopsy and the transrectal biopsy, we asked men immediately and at 7 days after biopsy to rate the amount of pain, discomfort, and anxiety they experienced on a scale of 0 to 10, a numerical rating scale. Right after biopsy, men rated more pain and discomfort with the transperineal approach relative to the transrectal approach. In other words, for pain, for example, the difference was 3.6 vs 3.0 on that 0 to 10 scale. It was a smaller difference for discomfort, but that also reached statistical significance. But then when we reassessed at 7 days afterwards, through a patient reported survey, there were no differences in pain, discomfort, and anxiety and no difference in anxiety at the time of the procedure. So, there is a statistically significant difference in that transperineal approach had more pain and discomfort compared to transrectal. But then when we also look at the acute pain literature or publications in the past, they tend to say that a clinically meaningful difference is a score of 1.6 or higher, which again, that .6 difference didn't reach.

So, in other words, those are the secondary end points that we measured beyond biopsy-related infection, that is cancer detection, as well as pain and discomfort. Going back to your question about future studies, through a Patient Centered Outcomes Research Institute award, we're enrolling patients after they've had a previous biopsy to look at the infection rate. That is, men who had a previously negative biopsy or those on active surveillance. The reason for that is that there are some studies that suggest that in the setting of a prior biopsy, there is a higher risk of infection. We'll again look at secondary end points like pain and discomfort, as well as differences in cancer detection, which are still relevant given that, as I mentioned earlier, there are more people on active surveillance, and it would be interesting to see if there's any differences in cancer detection rate based on differing biopsy approaches. That's the work that's on deck for that. There's less men who undergo biopsy for active surveillance or prior negative biopsy indications, so that's going to take a little bit more time to enroll.

Ultimately, our goal is–with Andrew Vickers, PhD, who's one of the foremost prostate cancer biostatisticians in the world–we will pull data from these 2 large, randomized trials, along with others that have been done, and better define, using prospective high-quality data, what the true risk of biopsy-related infections is for men. Our hope is to really change the practice of medicine. If we find that both of these approaches are equivalent and safer than what's traditionally out there with a 5% to 7% risk of infection, then that would suggest to practicing urologists to adopt either the transperineal approach or targeted prophylaxis. Over time if we find with greater sample size that the risk of infection with transperineal biopsy is statistically lower, then that would give further evidence to give policymakers and/or CMS, the Centers for Medicare and Medicaid Services, some guidance in terms of giving us a separate CPT code for transperineal vs transrectal biopsy. I do think one of the barriers to greater adoption of transperineal biopsy is that in the office setting, not only is there a learning curve to learn and adopt a new approach to doing biopsy, but there's also increased costs, particularly when you use this disposable device called the precision point. Currently, both approaches are being captured with the same CPT code, and therefore being afforded the same reimbursement.

This transcription has been edited for clarity.