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GU Cancers 2024 | Reducing infection in prostate cancer with transperineal prostate biopsies

Jim Hu, MD, Weill Cornell Medicine, New York, NY, discusses results from a multicenter, randomized trial (NCT04815876), where researchers compared transperineal biopsy without antibiotic prophylaxis to transrectal biopsy with targeted prophylaxis for prostate cancer detection. Transperineal biopsy showed zero infections, suggesting a potential reduction in infection risk and cancer detection rates were similar, supporting the efficacy of the transperineal approach. Despite patients undergoing transperineal biopsy experienced slightly more periprocedural pain, the effect was small and resolved by seven days. This interview took place at the ASCO GU Cancers Symposium 2024 in San Francisco, CA.

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Transcript (edited for clarity)

So really, this is the first multicenter, randomized, controlled trial to examine this important question. And, you know, I should contextualize by saying about 2 million men in Western Europe, as well as the US, undergo a prostate biopsy on an annual basis. And so one of the most devastating complications, of course, is an infection. And so the the reason we undertook this study is just to see whether we could find a newer and potentially better way of doing a biopsy...

So really, this is the first multicenter, randomized, controlled trial to examine this important question. And, you know, I should contextualize by saying about 2 million men in Western Europe, as well as the US, undergo a prostate biopsy on an annual basis. And so one of the most devastating complications, of course, is an infection. And so the the reason we undertook this study is just to see whether we could find a newer and potentially better way of doing a biopsy. That is the transperineal approach as compared to the traditional transrectal approach. And one one important caveat is that because the transperineal approach is performed with a needle going through the skin similar to, say, like a blood draw or putting in an IV, then, you know, the thought was, maybe you don’t need antibiotics as well, you know, at all, right, to prevent infection, whereas the traditional transrectal biopsy one gives antibiotics before the biopsy.

And so what we found basically in conducting the study was that, you know, out of about 287 men who had the the transperineal biopsy, we did not find any man had an infection. And of the 280 men that had a transrectal biopsy, um, a lower than expected number experienced an infection like four out of those 280, or about 1.4% experienced an infection. And so, in part of the reason why that rate is lower than what the systematic reviews or the review papers have contextualized, which is traditionally 5 to 7%, is the the type of preventative antibiotics we gave for the transrectal approach was where we did what’s called targeted prophylaxis. We did a rectal culture swab before the biopsy to see what if there were resistant bacteria in the rectum, and if there were, we changed the antibiotic that they got. So so, you know, that’s a more, um, rigorous way of doing the preventative antibiotics. And it’s also concordant what we terme antibiotic stewardship. That is, you know, if you prescribe multiple antibiotics, which a lot of people do prior to transrectal biopsy, that could actually worsen your your resistance rates and make the problem worse in the long run. And so so aside from the key finding that is, no infections versus a 1.4% risk of infections. And I should note that that that was not different statistically. Statistically meaning the p-value was 0.059. And so aside from that comparison, we also looked at the cancer detection differ. Like if, for example, if you did a newer approach to biopsy, although it could be the same or lower infection rate, but yet your likelihood of finding cancer is lower, then it’s obviously not as good an approach.

And what we found was the cancer detection rate in the transperineal arm was 53%. The cancer detection rate in the transrectal arm was 50%. And this is detection of what we call clinically significant cancer. And that also was not significantly different. Finally, we also compared tolerability or, you know, is the transperineal biopsy more painful or just the same as transrectal biopsy? And so we asked men, right, right after completion of the biopsy to rate their pain and discomfort on a 0 to 10 scale. And what we found was that on average, men undergoing transperineal biopsy rated the pain as 3.6. Transrectal, they rated as 3.0, that’s a statistically statistically significant difference. But clinical significance is thought to be a difference of about 1.6 or higher. And that difference in pain also resolved by one week after biopsy when we reassessed. And so so in summary, we found that, um, the infection risk of transperineal biopsies was 0% without the need for antibiotics. The infection risks for transrectal biopsy is 1.4%. With the use of targeted prophylaxis, there was no difference statistically, and there was no difference statistically in the detection rate of cancer. However, it appeared that the transperineal approach had a higher pain score 3.6 versus 3.0 for the transrectal approach.

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