Transperineal vs Transrectal Prostate Biopsy: Trial Findings and Discussion - Badar Mian
August 22, 2024
In this follow-up discussion, Badar Mian and E David Crawford delve deeper into the implications of clinical trials comparing transperineal (TP) and transrectal (TR) prostate biopsies. They address key issues such as antibiotic use, patient comfort, and sampling accuracy. Dr. Mian notes that many European centers still use antibiotics for TP biopsies, contrary to claims of antibiotic avoidance. They discuss the increased pain and potential embarrassment associated with TP biopsies, often leading to sedation use. The conversation highlights that the study found no significant difference in detecting anterior tumors between the two methods. Drs. Crawford and Mian emphasize the importance of having both techniques available and tailoring the approach to individual patient needs. They conclude that the study's results challenge the prevailing notion of TP biopsy superiority, suggesting a more balanced approach to biopsy method selection.
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: Clinical Trial Findings - Badar Mian
EAU 2024: Efficacy of Transrectal and Transperineal Prostate Biopsy in Detecting Clinically Significant Prostate Cancer: Results of the ProBE-PC Randomised Clinical Trial
Complications Following Transrectal and Transperineal Prostate Biopsy: Results of the ProBE-PC Randomized Clinical Trial.
Transperineal vs Transrectal Prostate Biopsy: Clinical Trial Findings - Badar Mian
EAU 2024: Efficacy of Transrectal and Transperineal Prostate Biopsy in Detecting Clinically Significant Prostate Cancer: Results of the ProBE-PC Randomised Clinical Trial
Complications Following Transrectal and Transperineal Prostate Biopsy: Results of the ProBE-PC Randomized Clinical Trial.
Read the Full Video Transcript
E. David Crawford: That was an outstanding presentation. A great clinical trial. Two simple endpoints, enough patients that show, in my opinion, and I think most others', that there's an equivalence here. Let's talk about a couple of things. The proponents of transperineal focus on avoiding antibiotic prophylaxis, which is not used by many who are doing transperineal. What are your thoughts about that?
Badar Mian: When we devised the trial at that time, this was a novel idea. There were really not very many studies to support that. In fact, we got criticized during the publication process for the fact that we didn't use antibiotics in the TP group, creating an imbalance. So, what we thought was a potential plus was actually criticized by even the proponents because they had thought that if you had used antibiotics for TP as well, the rate would be even lower. But how much lower can you get from 0.3% is difficult to say. So, it was interesting.
Now it turns out that the centers in Europe that do a lot of TP biopsies are using antibiotics for it. Yes, the groups in London and also in other parts of Europe, that's their standard approach. They use antibiotics for it. Some trials are pending that they’re waiting for. But even though we've demonstrated that antibiotics can be safely omitted for most people, we did use them in certain individuals who met high-risk criteria as we could utilize. So, you can tailor the approach. But although the proponents are using that as a reason to promote further, despite all the data that negates the idea, that because you can skip one day of antibiotics, which is what we use. We did not use more than one day. In fact—
E. David Crawford: What antibiotic did you use generally?
Badar Mian: Because of the existing protocol that has been with us for a long time, we typically use one Cipro and one Bactrim pre-biopsy. And then one Cipro and one Bactrim that night. And that's it. Lately, we have been using one injection, one gram of ceftriaxone IM. So, that's been our protocol. Others still have a concern that I think needs to be addressed by everybody, which is the prolonged prophylaxis that we sometimes still see being performed. Again, in Europe, I was at the EAU meeting recently, and a lot of folks came and discussed these biopsy-related questions, and surprisingly, a high number of centers are using more than single-day prophylaxis. So, I think that in itself requires a discussion. But I think it is safe to skip antibiotics for most patients undergoing transperineal. Does that have a large impact on patients? That’s a different question.
E. David Crawford: The whole thing about antibiotics and antibiotic stewardship, but I think what really drove a lot of the clinicians to use transperineal was that I have 3%, 5% incidents of serious problems and infections after transrectal. And I think that there is a slightly higher risk. And you almost always should use antibiotics for transrectal. We're doing stool cultures and looking for resistance before we do them. There are a lot of different approaches. And then the French studies and different things were used, as you pointed out. I think the key is if you do it judiciously, and I don't know if you need to use antibiotics after the transperineal approach. We didn't a lot. It had sort of equal results.
I guess the next thing is this, and this is what bothers me a lot, is that, number one, the transrectal biopsy, if you do them correctly, and inject somebody, wait 10 minutes before you start your biopsies, do a good injection. It's uncomfortable, but it's not unbearable. That's not exactly the case for transperineal, even with skilled clinicians. And what I see—maybe comment on this—a lot of these are being done in outpatient surgery, that's what's been happening in our place, with an anesthetic.
Badar Mian: They are. And again, go back to the mecca of TP biopsies, Europe and European centers, London, they are doing most biopsies under sedation. So, they utilize antibiotics for TP and sedation for TP. Our trial was opposite. We actually didn't use any sedation, but most are done under sedation. It is painful. There's no question about it. You can call it transient pain. We can call it only a three-point difference, two-point difference, and clinically not a meaningful difference based on what prism you're looking through. You can make it look not significant versus significant, but there's no question about it. The block is more painful, from skin to the muscles. With skilled hands, it is still more painful. And unskilled hands probably shouldn't be doing it. And there's another factor. A study published in the Gold Journal reported that patients felt more embarrassed with that approach, which I had not seen before. So, they asked a question in the lithotomy position, and patients reported more embarrassment than in the left lateral position, which is interesting to me.
E. David Crawford: Very interesting. One of the other things I think that your answers are important about is sampling of the gland. We heard that the anterior, apex, and all this other stuff is more accessible transperineally. I think you put that to rest with the results of your biopsies.
Badar Mian: We had a large number of patients, about 300 some patients, who had tumors that were anterior. And we found no difference in being able to detect them. So, if you have a target that you can see, whether it's ultrasound, whether it's high intensity, high resolution ultrasound, or it's UroNav or any platform you use, if you have targeting ability, then location should not matter. It never made sense to me why targeting should make any difference, and it did not make a difference in our study. In the French study, interestingly, they had a better result with TP for anterior tumors, but better results with transrectal for the posterior tumors.
E. David Crawford: That makes sense.
Badar Mian: Yeah.
E. David Crawford: So, there's no question there are additional skills that are required with transperineal, and even the change with transrectal. Now, I don't know if you've been involved with micro ultrasound or not using that. I think that's been a game changer, too.
Badar Mian: Yeah, I've used it. We don't have it at our site. We have used it. And yeah, it can make the biopsy more accessible, targeting biopsy more accessible because you can skip the platforms that are expensive to have. But the interesting part is that the proponents are doing something that we have said probably is not necessary, which is sedation, as well as antibiotics. So, that question will come up and will need to be resolved.
E. David Crawford: Let me just finish up with this, and I see this almost every week when I'm in the clinic, is that you're scheduling a person for a biopsy and the patient right away wants to know, "Do you do transperineal biopsies?" And then you tell them, well, you do them both ways or various. It depends on the patient and things like that. "Now no doc, I want the transperineal because there's less risk of infection and better results." I think your study refutes that pretty strongly. Comments?
Badar Mian: Well, it doesn't. So, I do both also. Any given week depends on the schedule, what slot is open. Because we did build the infrastructure to do the study, to put all the pieces in place, and there's a cost that you have to incur to start a TP program. There's no question about it. To get the UroNav platform for TP as well. At the moment when patients come in, we tell them, "We're going to schedule you for a prostate biopsy with any slot that's open." If somebody is really insistent on it or they have had a bad experience elsewhere, or somebody already had a [inaudible 00:08:55] somewhere else, we would let them pick it. But we do not tell our staff, for example, what to schedule. Whatever slot's open, the patient goes in the slot, except the ones who are insisting on one or the other. And the word, at least locally, is out that we do both, and we have had equally good results with both approaches. So, the pushback has actually, in our area, improved. But as you said, the internet is full of these claims of "superiority," that may take a while to disappear.
E. David Crawford: Yeah. Well, and that takes the results of a trial like you did to prove that. I see patients, too, who get transrectal, who have had transperineal, and we’re following them on active surveillance or things like that, and they go, "My gosh, Doc, what a difference that makes to do it correctly." So, I think you have both tools in your armamentarium. But I think this heavy push towards using this is— you’ve answered that. So, anyway, I want to thank you and your colleagues, Hugh Fisher, and everybody else at your institution who did this very difficult study and came out with these results. Thanks a lot.
Badar Mian: Thank you very much for having me.
E. David Crawford: That was an outstanding presentation. A great clinical trial. Two simple endpoints, enough patients that show, in my opinion, and I think most others', that there's an equivalence here. Let's talk about a couple of things. The proponents of transperineal focus on avoiding antibiotic prophylaxis, which is not used by many who are doing transperineal. What are your thoughts about that?
Badar Mian: When we devised the trial at that time, this was a novel idea. There were really not very many studies to support that. In fact, we got criticized during the publication process for the fact that we didn't use antibiotics in the TP group, creating an imbalance. So, what we thought was a potential plus was actually criticized by even the proponents because they had thought that if you had used antibiotics for TP as well, the rate would be even lower. But how much lower can you get from 0.3% is difficult to say. So, it was interesting.
Now it turns out that the centers in Europe that do a lot of TP biopsies are using antibiotics for it. Yes, the groups in London and also in other parts of Europe, that's their standard approach. They use antibiotics for it. Some trials are pending that they’re waiting for. But even though we've demonstrated that antibiotics can be safely omitted for most people, we did use them in certain individuals who met high-risk criteria as we could utilize. So, you can tailor the approach. But although the proponents are using that as a reason to promote further, despite all the data that negates the idea, that because you can skip one day of antibiotics, which is what we use. We did not use more than one day. In fact—
E. David Crawford: What antibiotic did you use generally?
Badar Mian: Because of the existing protocol that has been with us for a long time, we typically use one Cipro and one Bactrim pre-biopsy. And then one Cipro and one Bactrim that night. And that's it. Lately, we have been using one injection, one gram of ceftriaxone IM. So, that's been our protocol. Others still have a concern that I think needs to be addressed by everybody, which is the prolonged prophylaxis that we sometimes still see being performed. Again, in Europe, I was at the EAU meeting recently, and a lot of folks came and discussed these biopsy-related questions, and surprisingly, a high number of centers are using more than single-day prophylaxis. So, I think that in itself requires a discussion. But I think it is safe to skip antibiotics for most patients undergoing transperineal. Does that have a large impact on patients? That’s a different question.
E. David Crawford: The whole thing about antibiotics and antibiotic stewardship, but I think what really drove a lot of the clinicians to use transperineal was that I have 3%, 5% incidents of serious problems and infections after transrectal. And I think that there is a slightly higher risk. And you almost always should use antibiotics for transrectal. We're doing stool cultures and looking for resistance before we do them. There are a lot of different approaches. And then the French studies and different things were used, as you pointed out. I think the key is if you do it judiciously, and I don't know if you need to use antibiotics after the transperineal approach. We didn't a lot. It had sort of equal results.
I guess the next thing is this, and this is what bothers me a lot, is that, number one, the transrectal biopsy, if you do them correctly, and inject somebody, wait 10 minutes before you start your biopsies, do a good injection. It's uncomfortable, but it's not unbearable. That's not exactly the case for transperineal, even with skilled clinicians. And what I see—maybe comment on this—a lot of these are being done in outpatient surgery, that's what's been happening in our place, with an anesthetic.
Badar Mian: They are. And again, go back to the mecca of TP biopsies, Europe and European centers, London, they are doing most biopsies under sedation. So, they utilize antibiotics for TP and sedation for TP. Our trial was opposite. We actually didn't use any sedation, but most are done under sedation. It is painful. There's no question about it. You can call it transient pain. We can call it only a three-point difference, two-point difference, and clinically not a meaningful difference based on what prism you're looking through. You can make it look not significant versus significant, but there's no question about it. The block is more painful, from skin to the muscles. With skilled hands, it is still more painful. And unskilled hands probably shouldn't be doing it. And there's another factor. A study published in the Gold Journal reported that patients felt more embarrassed with that approach, which I had not seen before. So, they asked a question in the lithotomy position, and patients reported more embarrassment than in the left lateral position, which is interesting to me.
E. David Crawford: Very interesting. One of the other things I think that your answers are important about is sampling of the gland. We heard that the anterior, apex, and all this other stuff is more accessible transperineally. I think you put that to rest with the results of your biopsies.
Badar Mian: We had a large number of patients, about 300 some patients, who had tumors that were anterior. And we found no difference in being able to detect them. So, if you have a target that you can see, whether it's ultrasound, whether it's high intensity, high resolution ultrasound, or it's UroNav or any platform you use, if you have targeting ability, then location should not matter. It never made sense to me why targeting should make any difference, and it did not make a difference in our study. In the French study, interestingly, they had a better result with TP for anterior tumors, but better results with transrectal for the posterior tumors.
E. David Crawford: That makes sense.
Badar Mian: Yeah.
E. David Crawford: So, there's no question there are additional skills that are required with transperineal, and even the change with transrectal. Now, I don't know if you've been involved with micro ultrasound or not using that. I think that's been a game changer, too.
Badar Mian: Yeah, I've used it. We don't have it at our site. We have used it. And yeah, it can make the biopsy more accessible, targeting biopsy more accessible because you can skip the platforms that are expensive to have. But the interesting part is that the proponents are doing something that we have said probably is not necessary, which is sedation, as well as antibiotics. So, that question will come up and will need to be resolved.
E. David Crawford: Let me just finish up with this, and I see this almost every week when I'm in the clinic, is that you're scheduling a person for a biopsy and the patient right away wants to know, "Do you do transperineal biopsies?" And then you tell them, well, you do them both ways or various. It depends on the patient and things like that. "Now no doc, I want the transperineal because there's less risk of infection and better results." I think your study refutes that pretty strongly. Comments?
Badar Mian: Well, it doesn't. So, I do both also. Any given week depends on the schedule, what slot is open. Because we did build the infrastructure to do the study, to put all the pieces in place, and there's a cost that you have to incur to start a TP program. There's no question about it. To get the UroNav platform for TP as well. At the moment when patients come in, we tell them, "We're going to schedule you for a prostate biopsy with any slot that's open." If somebody is really insistent on it or they have had a bad experience elsewhere, or somebody already had a [inaudible 00:08:55] somewhere else, we would let them pick it. But we do not tell our staff, for example, what to schedule. Whatever slot's open, the patient goes in the slot, except the ones who are insisting on one or the other. And the word, at least locally, is out that we do both, and we have had equally good results with both approaches. So, the pushback has actually, in our area, improved. But as you said, the internet is full of these claims of "superiority," that may take a while to disappear.
E. David Crawford: Yeah. Well, and that takes the results of a trial like you did to prove that. I see patients, too, who get transrectal, who have had transperineal, and we’re following them on active surveillance or things like that, and they go, "My gosh, Doc, what a difference that makes to do it correctly." So, I think you have both tools in your armamentarium. But I think this heavy push towards using this is— you’ve answered that. So, anyway, I want to thank you and your colleagues, Hugh Fisher, and everybody else at your institution who did this very difficult study and came out with these results. Thanks a lot.
Badar Mian: Thank you very much for having me.