Transperineal vs Transrectal Prostate Biopsy: Clinical Trial Findings - Badar Mian
August 22, 2024
Badar Mian discusses randomized clinical trials comparing transperineal (TP) and transrectal (TR) prostate biopsy approaches. Despite previous beliefs favoring TP biopsies for lower infection rates and better cancer detection, three major trials (ProBE-PC, PREVENT, and PERFECT) show no significant differences in sepsis rates or cancer detection between the two methods. The studies reveal similar minor infection rates requiring brief hospitalizations, with no cases of sepsis in either group. Cancer detection rates, particularly for Grade 2 or higher, are comparable between TP and TR approaches across all trials. Dr. Mian concludes that current evidence does not demonstrate clear superiority of the TP approach over TR. He notes that questions remain regarding pain levels, costs, and antibiotic prophylaxis implications for both methods. This research challenges the trend towards favoring TP biopsies and suggests a need for further evaluation of both approaches.
Biographies:
Badar Mian, MD, Urologist, Professor of Surgery, Albany Medical Center, Albany, NY
E. David Crawford, MD, Urologist, Professor of Urology, Jack A. Vickers Director of Prostate Cancer Research, University of California San Diego, San Diego Health, San Diego, CA, The University of Colorado Anschutz Medical Campus, Aurora, CO
Biographies:
Badar Mian, MD, Urologist, Professor of Surgery, Albany Medical Center, Albany, NY
E. David Crawford, MD, Urologist, Professor of Urology, Jack A. Vickers Director of Prostate Cancer Research, University of California San Diego, San Diego Health, San Diego, CA, The University of Colorado Anschutz Medical Campus, Aurora, CO
Related Content:
Transperineal vs Transrectal Prostate Biopsy: Trial Findings and Discussion - Badar Mian
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Complications Following Transrectal and Transperineal Prostate Biopsy: Results of the ProBE-PC Randomized Clinical Trial.
Transperineal vs Transrectal Prostate Biopsy: Trial Findings and Discussion - Badar Mian
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Read the Full Video Transcript
E. David Crawford: Greetings, everyone. I'm E. David Crawford. I'm a professor of urology in the Department of Urology at the University of California in San Diego.
It was over a decade ago that we embarked on a transperineal mapping biopsy program in over 800 men for our targeted focal therapy treatment program. The concept was based on Winston Barzell and Gary Onik using a brachytherapy grid at 5-millimeter intervals. We did about two biopsies per cc of prostate size, sometimes performing between 20 and 170 biopsies.
The upshot was we could accurately identify where lesions were for targeted therapy, and we reported really no septic or significant episodes like that. However, over the past few years, there has been concern about increased septic episodes from transrectal ultrasound-guided biopsies and belief, also, that you got better sampling with transperineal approaches. There's been an international trend gravitating, basically condemning the transrectal ultrasound-guided biopsy approach and promoting the transperineal approach. What is needed, like in many things when there are questions in medicine, is a randomized clinical trial.
Joining me is Dr. Badar Mian, who will share with us, I think, one of the most significant randomized clinical trials that has been done in diagnosing prostate cancer in the last few years, if not the last decade. Dr. Mian is Professor of Urology at Albany Med in Albany, New York. Welcome, and thanks for sharing this with our audience.
Badar Mian: Thank you so much, Dr. Crawford, for having me to discuss this very important topic that's, of course, been close to your heart for many, many years. I've watched your work for many years, and I wanted to discuss what we discovered in our randomized clinical trials, and then some others followed. This question about whether the transperineal prostate biopsy is superior to the transrectal approach has come up for the last many years, mainly because there have been a number of retrospective and observational studies that stated, reported, that there is a much lower risk of infectious complications, such as hospitalization and urosepsis, following the TP approach when compared to transrectal.
Of course, there has been antibiotic resistance developing throughout the country, and the world, in fact, so the concerns, at least, were valid and required studying. They also had reported in other studies previously that there is an increased rate of cancer detection with the TP approach by virtue of its approach to the prostate being craniocaudal versus anteroposterior.
So the TP approach in the last many years has become trendy, became kind of the thing to do, and that's how we got into it in the first place because we were all doing it, wanted to be with the Joneses, and it's often still referred to as the superior approach compared to transrectal. In fact, the EU guidelines report this to be their preferred approach over the transrectal approach.
This side had become a done deal for a lot of people in Europe and also in the USA until we proposed and completed a randomized clinical trial called the ProBE-PC trial, and then other trials followed called the PREVENT and PERFECT trials. Interestingly, in all three trials, there was not a single episode of sepsis. Urosepsis did not occur in these three trials at all. So what we had left were minor infections, hospitalization is what we can look at now.
In our study of 718 patients, there were two patients in the transrectal group that came into the hospital and required IV antibiotics. One of them stayed because of social reasons, so none of the patients were septic. In the trial that followed ours, the PREVENT trial, they had four patients that came into the hospital requiring IV antibiotics and were admitted overnight. Admissions were mostly one-night stays for 24 to 48 hours, no prolonged hospitalizations, again, not septic, but had an infection. And the French trial, the PERFECT trial, also had a single patient that came into the hospital, got IV antibiotics, and stayed one night. So all these patients were not septic but had infections that required treatment. So that's one aspect.
The second aspect that had come into question is the rate of cancer detection, especially Grade 2 or higher. We're going to look at three trials: our trial and then the subsequent trials, in men who are biopsy-naive and are undergoing MRI-targeted biopsy, which is kind of the standard now. If you look at the rates, the rates are high and similar across all three studies between the transrectal and transperineal. Our rate was 59% and 62% in transrectal and transperineal. The French study was a non-inferiority study, where they were going to accept up to a 5% lower rate of detection with TP and still call that okay. They could not meet that target, so they actually had a lower rate of cancer detection, at 47% in the TP group and 54% in the transrectal group.
So we can quickly summarize then, based on these trials, that the complication rates among the transrectal and transperineal approaches are similar. And the same can be said for the cancer detection rates between the two procedures. So far, with the best available evidence from three randomized trials, there's no clear superiority of the TP approach that can be demonstrated.
And then we do have a few questions that are lingering and require addressing and discussion. Is the TP approach more painful than transrectal? And many would say yes. The cost question is also to be addressed. And then, finally, there's a question about the antibiotic prophylaxis and what the implications of that are for both transrectal and transperineal and whether it has any impact on our decision-making process. Thank you so much.
E. David Crawford: Greetings, everyone. I'm E. David Crawford. I'm a professor of urology in the Department of Urology at the University of California in San Diego.
It was over a decade ago that we embarked on a transperineal mapping biopsy program in over 800 men for our targeted focal therapy treatment program. The concept was based on Winston Barzell and Gary Onik using a brachytherapy grid at 5-millimeter intervals. We did about two biopsies per cc of prostate size, sometimes performing between 20 and 170 biopsies.
The upshot was we could accurately identify where lesions were for targeted therapy, and we reported really no septic or significant episodes like that. However, over the past few years, there has been concern about increased septic episodes from transrectal ultrasound-guided biopsies and belief, also, that you got better sampling with transperineal approaches. There's been an international trend gravitating, basically condemning the transrectal ultrasound-guided biopsy approach and promoting the transperineal approach. What is needed, like in many things when there are questions in medicine, is a randomized clinical trial.
Joining me is Dr. Badar Mian, who will share with us, I think, one of the most significant randomized clinical trials that has been done in diagnosing prostate cancer in the last few years, if not the last decade. Dr. Mian is Professor of Urology at Albany Med in Albany, New York. Welcome, and thanks for sharing this with our audience.
Badar Mian: Thank you so much, Dr. Crawford, for having me to discuss this very important topic that's, of course, been close to your heart for many, many years. I've watched your work for many years, and I wanted to discuss what we discovered in our randomized clinical trials, and then some others followed. This question about whether the transperineal prostate biopsy is superior to the transrectal approach has come up for the last many years, mainly because there have been a number of retrospective and observational studies that stated, reported, that there is a much lower risk of infectious complications, such as hospitalization and urosepsis, following the TP approach when compared to transrectal.
Of course, there has been antibiotic resistance developing throughout the country, and the world, in fact, so the concerns, at least, were valid and required studying. They also had reported in other studies previously that there is an increased rate of cancer detection with the TP approach by virtue of its approach to the prostate being craniocaudal versus anteroposterior.
So the TP approach in the last many years has become trendy, became kind of the thing to do, and that's how we got into it in the first place because we were all doing it, wanted to be with the Joneses, and it's often still referred to as the superior approach compared to transrectal. In fact, the EU guidelines report this to be their preferred approach over the transrectal approach.
This side had become a done deal for a lot of people in Europe and also in the USA until we proposed and completed a randomized clinical trial called the ProBE-PC trial, and then other trials followed called the PREVENT and PERFECT trials. Interestingly, in all three trials, there was not a single episode of sepsis. Urosepsis did not occur in these three trials at all. So what we had left were minor infections, hospitalization is what we can look at now.
In our study of 718 patients, there were two patients in the transrectal group that came into the hospital and required IV antibiotics. One of them stayed because of social reasons, so none of the patients were septic. In the trial that followed ours, the PREVENT trial, they had four patients that came into the hospital requiring IV antibiotics and were admitted overnight. Admissions were mostly one-night stays for 24 to 48 hours, no prolonged hospitalizations, again, not septic, but had an infection. And the French trial, the PERFECT trial, also had a single patient that came into the hospital, got IV antibiotics, and stayed one night. So all these patients were not septic but had infections that required treatment. So that's one aspect.
The second aspect that had come into question is the rate of cancer detection, especially Grade 2 or higher. We're going to look at three trials: our trial and then the subsequent trials, in men who are biopsy-naive and are undergoing MRI-targeted biopsy, which is kind of the standard now. If you look at the rates, the rates are high and similar across all three studies between the transrectal and transperineal. Our rate was 59% and 62% in transrectal and transperineal. The French study was a non-inferiority study, where they were going to accept up to a 5% lower rate of detection with TP and still call that okay. They could not meet that target, so they actually had a lower rate of cancer detection, at 47% in the TP group and 54% in the transrectal group.
So we can quickly summarize then, based on these trials, that the complication rates among the transrectal and transperineal approaches are similar. And the same can be said for the cancer detection rates between the two procedures. So far, with the best available evidence from three randomized trials, there's no clear superiority of the TP approach that can be demonstrated.
And then we do have a few questions that are lingering and require addressing and discussion. Is the TP approach more painful than transrectal? And many would say yes. The cost question is also to be addressed. And then, finally, there's a question about the antibiotic prophylaxis and what the implications of that are for both transrectal and transperineal and whether it has any impact on our decision-making process. Thank you so much.