Review of Transperineal and Transrectal Prostate Biopsy Outcomes - Beyond the Abstract
September 9, 2025
More than 2 million prostate biopsies are performed annually in the USA and Europe, but there is debate over the optimal approach. The procedural time is shorter for transrectal (TR) than for transperineal (TP) biopsy, but prospective randomized trials have demonstrated that TR biopsy has a greater risk of infectious complications and inferior cancer detection rates.
Biographies:
Jim C. Hu, MD, MPH, Department of Urology, Weill Cornell Medicine, NewYork-Presbyterian Hospital, New York, NY, USA
Biographies:
Jim C. Hu, MD, MPH, Department of Urology, Weill Cornell Medicine, NewYork-Presbyterian Hospital, New York, NY, USA
Read the Full Video Transcript
Jim Hu: I'm Jim Hu, professor of Urology at Weill Cornell Medicine, I'm delighted to give this Beyond the Abstract UroToday presentation looking at a review of the transperineal versus transrectal randomized control trials. I'm just going to share a screen and then do the slideshow here. Okay, here we go. So, credit to my co-authors, especially Evan Suzman, who did a wonderful job with the heavy lifting on putting this together. This is available online as of August 5th, 2025. So, the impetus for many of these randomized trials is due to the fact that there was noted to be an increasing risk of infection post-transrectal biopsy. This white paper from 2017, from the American Urological Association estimated a five to 7% post-biopsy infection risk, as well as a one to 3% post-transrectal biopsy risk of hospitalization. And due to the increasing risk of antimicrobial resistance, alternative strategies such as augmented prophylaxis, targeted prophylaxis, and transperineal biopsy were proposed.
At the time of the white paper, transperineal biopsy was largely performed via the top figure, that is the traditional brachytherapy grid with saturation biopsies conducted under sedation or under general anesthesia in the operating room. Below, you see the more contemporary approach using the precision point device and local anesthesia here in the office setting. This was the first randomized trial from the Albany Group, published in February 2024, where we see a composite definition for post-biopsy infection that did not differ, 2.7 versus 2.6% for the transrectal in blue, versus transperineal in orange. There were no episodes of sepsis. However, the post-biopsy composite infection definition included emergency room visits as well as telephone calls, prescriptions. Therefore, it was a very nonspecific definition, which may be problematic because there was significant overlap with the COVID pandemic when this trial was conducted. The rationale for many of these studies, at least in the transperineal arm, for not using any antibiotic prophylaxis comes from the Society for Interventional Radiology, which stated that antibiotic prophylaxis is unnecessary for clean percutaneous procedures.
Similarly, we conducted a randomized controlled trial as well, our primary outcome was post-biopsy infection, we did not use antibiotic prophylaxis in the transperineal arm, the transrectal arm, we used targeted prophylaxis, which is unique amongst the randomized trials, and we had standardized definition of infections, which you see here, that is uncomplicated urinary tract infections, complicated urinary tract infections, as well as urosepsis. And the significant findings, we did find that there were no infections in the transperineal biopsy arm, versus six infections in the transrectal biopsy arm, which reached statistical significance. We also looked at secondary outcomes of the biopsy detection of clinically significant cancer; this was 55% with TP biopsy, versus 52% with TR or transrectal, which did not approach statistical significance. Another secondary outcome was comparing biopsy pain, and on a zero to 10 visual analog score or numerical rating scale, the transperineal participants rated their pain as 3.7, versus 3.1 for the transrectal arm, which reached statistical significance.
When we look at details on the men who experienced infections, we can see that there were no sepsis episodes; some of these were treated by the primary care physician just using oral antibiotics, others came to the emergency room, and you can see that in half of the infections there was resistance to the fluoroquinolone on the transrectal biopsy swab. Now, this is the PERFECT trial that was conducted in France, this was a largely primary outcome comparison of detection of clinically significant cancer, and you can see via this main result slide, that when we looked at overall detection of clinically significant cancer, there was no significant difference, when there was further stratification by anterior versus posterior lesion, you can see there were trends, however, the P-value, again, for comparing overall differences did not differ, or did not reach the statistical significance.
There was noted to be one transrectal patient who had experienced a grade three sepsis, however, this was not the primary outcome. Additionally, it was unclear the proportion of patients that underwent a general anesthetic or local anesthetic approach to the transperineal versus transrectal biopsy. It's also unclear what the type of prophylaxis these patients received was, and again, with unknown amounts of patients undergoing a transperineal biopsy under general or local anesthesia, the pain scores are rather difficult to interpret, particularly when they're assessed on post-op day zero or post-op day one. This is the TRANSLATE study that came from the UK, the most recent study published in May 2025. The primary outcome of this study was comparison of the detection of clinically significant cancer, and you can see that the transperineal approach, the detection rate was 60%, versus the transrectal approach the detection was 54%, and this did reach statistical significance. Additionally, the secondary outcome in this study was infections that caused hospitalization, and here the authors did not use the exact proportion; they just said less than 1%.
There was one infection in the transperineal arm that led to a hospitalization by seven days, versus seven in the transrectal arm, however, that odds ratio 95% confidence interval crossed one, and therefore did not reach statistical significance. However, when we looked at these studies in a tabular format, we did take into account the actual percentage. If you looked at the 0.02% versus a 1.2% risk of infection of the TRANSLATE study, that P-value becomes 0.033. Also important to note is the prophylaxis was none for the transperineal approach, which is similar to the PREVENT trial as well as the ProBE-PC versus augmented. And so, again, unique to the prophylaxis', and prevent our study, we use targeted prophylaxis. You can also see the differentiation of how randomization was assigned. In the ALBANY study, it was a coin flip. Additionally, ALBANY included men with prior biopsy, whereas the other three studies were all first time biopsies. And you can see that in the PREVENT and TRANSLATE studies that the P-values were statistically significant, again, bearing in mind that the infection definitions differed across the studies.
Additionally, when we looked at the infection timeframe, we did seven days because literature review shows that post-biopsy infections 99% occur within seven days; the studies that looked at, rigorously looked at differences in pain also noticed the significant differences that favored the transrectal approach. Here, looking at significant extreme pain, we had 7% versus 3%, which favored lower pain in the transrectal biopsy approach. In terms of the cores, you can see that most had the same amount of sampling between arms, although in the PERFECT study, TP, biopsy had, I would say significantly fewer biopsy cores compared to the transrectal approach. Finally, when we look at detection of clinically significant cancer, you can see that the TRANSLATE study is the only one that showed significantly more cancers captured with the transperineal approach, a difference, absolute difference of 6%.
That absolute difference in the PREVENT study, our study, was only 3%, did not reach statistical significance, and in terms of looking at how diverse the population was, ours comprised 37%... 37% of the men in our study were non-white, and one can see a single-center versus multi-center differences in the following row, as well as the number of urologists who participated in the study. So, in summary, no prophylaxis is required for transperineal biopsy is shown. By three of the randomized controlled trials, transperineal biopsy is more painful than transrectal biopsy according to both TRANSLATE as well as PREVENT. There's no significant differences in urinary retention and bleeding complications. I think urinary retention was thought to be higher traditionally because transperineal biopsy saturation approach was performed under sedation or general anesthesia.
When we exclude studies that had nonspecific infection definitions, such as telephone calls, prescriptions, and so forth, transperineal has fewer infections than transrectal biopsy, again, per the PREVENT study as well as TRANSLATE, there's mixed results on cancer detection with only TRANSLATE showing a 6% increased detection of clinically significant cancer with transperineal biopsy. And finally, enrollment for PREVENT 2, that is a patient-centered outcomes research institution funded study for prior negative and active surveillance biopsies with the primary outcome of infection is ongoing. Thank you for your attention.
Jim Hu: I'm Jim Hu, professor of Urology at Weill Cornell Medicine, I'm delighted to give this Beyond the Abstract UroToday presentation looking at a review of the transperineal versus transrectal randomized control trials. I'm just going to share a screen and then do the slideshow here. Okay, here we go. So, credit to my co-authors, especially Evan Suzman, who did a wonderful job with the heavy lifting on putting this together. This is available online as of August 5th, 2025. So, the impetus for many of these randomized trials is due to the fact that there was noted to be an increasing risk of infection post-transrectal biopsy. This white paper from 2017, from the American Urological Association estimated a five to 7% post-biopsy infection risk, as well as a one to 3% post-transrectal biopsy risk of hospitalization. And due to the increasing risk of antimicrobial resistance, alternative strategies such as augmented prophylaxis, targeted prophylaxis, and transperineal biopsy were proposed.
At the time of the white paper, transperineal biopsy was largely performed via the top figure, that is the traditional brachytherapy grid with saturation biopsies conducted under sedation or under general anesthesia in the operating room. Below, you see the more contemporary approach using the precision point device and local anesthesia here in the office setting. This was the first randomized trial from the Albany Group, published in February 2024, where we see a composite definition for post-biopsy infection that did not differ, 2.7 versus 2.6% for the transrectal in blue, versus transperineal in orange. There were no episodes of sepsis. However, the post-biopsy composite infection definition included emergency room visits as well as telephone calls, prescriptions. Therefore, it was a very nonspecific definition, which may be problematic because there was significant overlap with the COVID pandemic when this trial was conducted. The rationale for many of these studies, at least in the transperineal arm, for not using any antibiotic prophylaxis comes from the Society for Interventional Radiology, which stated that antibiotic prophylaxis is unnecessary for clean percutaneous procedures.
Similarly, we conducted a randomized controlled trial as well, our primary outcome was post-biopsy infection, we did not use antibiotic prophylaxis in the transperineal arm, the transrectal arm, we used targeted prophylaxis, which is unique amongst the randomized trials, and we had standardized definition of infections, which you see here, that is uncomplicated urinary tract infections, complicated urinary tract infections, as well as urosepsis. And the significant findings, we did find that there were no infections in the transperineal biopsy arm, versus six infections in the transrectal biopsy arm, which reached statistical significance. We also looked at secondary outcomes of the biopsy detection of clinically significant cancer; this was 55% with TP biopsy, versus 52% with TR or transrectal, which did not approach statistical significance. Another secondary outcome was comparing biopsy pain, and on a zero to 10 visual analog score or numerical rating scale, the transperineal participants rated their pain as 3.7, versus 3.1 for the transrectal arm, which reached statistical significance.
When we look at details on the men who experienced infections, we can see that there were no sepsis episodes; some of these were treated by the primary care physician just using oral antibiotics, others came to the emergency room, and you can see that in half of the infections there was resistance to the fluoroquinolone on the transrectal biopsy swab. Now, this is the PERFECT trial that was conducted in France, this was a largely primary outcome comparison of detection of clinically significant cancer, and you can see via this main result slide, that when we looked at overall detection of clinically significant cancer, there was no significant difference, when there was further stratification by anterior versus posterior lesion, you can see there were trends, however, the P-value, again, for comparing overall differences did not differ, or did not reach the statistical significance.
There was noted to be one transrectal patient who had experienced a grade three sepsis, however, this was not the primary outcome. Additionally, it was unclear the proportion of patients that underwent a general anesthetic or local anesthetic approach to the transperineal versus transrectal biopsy. It's also unclear what the type of prophylaxis these patients received was, and again, with unknown amounts of patients undergoing a transperineal biopsy under general or local anesthesia, the pain scores are rather difficult to interpret, particularly when they're assessed on post-op day zero or post-op day one. This is the TRANSLATE study that came from the UK, the most recent study published in May 2025. The primary outcome of this study was comparison of the detection of clinically significant cancer, and you can see that the transperineal approach, the detection rate was 60%, versus the transrectal approach the detection was 54%, and this did reach statistical significance. Additionally, the secondary outcome in this study was infections that caused hospitalization, and here the authors did not use the exact proportion; they just said less than 1%.
There was one infection in the transperineal arm that led to a hospitalization by seven days, versus seven in the transrectal arm, however, that odds ratio 95% confidence interval crossed one, and therefore did not reach statistical significance. However, when we looked at these studies in a tabular format, we did take into account the actual percentage. If you looked at the 0.02% versus a 1.2% risk of infection of the TRANSLATE study, that P-value becomes 0.033. Also important to note is the prophylaxis was none for the transperineal approach, which is similar to the PREVENT trial as well as the ProBE-PC versus augmented. And so, again, unique to the prophylaxis', and prevent our study, we use targeted prophylaxis. You can also see the differentiation of how randomization was assigned. In the ALBANY study, it was a coin flip. Additionally, ALBANY included men with prior biopsy, whereas the other three studies were all first time biopsies. And you can see that in the PREVENT and TRANSLATE studies that the P-values were statistically significant, again, bearing in mind that the infection definitions differed across the studies.
Additionally, when we looked at the infection timeframe, we did seven days because literature review shows that post-biopsy infections 99% occur within seven days; the studies that looked at, rigorously looked at differences in pain also noticed the significant differences that favored the transrectal approach. Here, looking at significant extreme pain, we had 7% versus 3%, which favored lower pain in the transrectal biopsy approach. In terms of the cores, you can see that most had the same amount of sampling between arms, although in the PERFECT study, TP, biopsy had, I would say significantly fewer biopsy cores compared to the transrectal approach. Finally, when we look at detection of clinically significant cancer, you can see that the TRANSLATE study is the only one that showed significantly more cancers captured with the transperineal approach, a difference, absolute difference of 6%.
That absolute difference in the PREVENT study, our study, was only 3%, did not reach statistical significance, and in terms of looking at how diverse the population was, ours comprised 37%... 37% of the men in our study were non-white, and one can see a single-center versus multi-center differences in the following row, as well as the number of urologists who participated in the study. So, in summary, no prophylaxis is required for transperineal biopsy is shown. By three of the randomized controlled trials, transperineal biopsy is more painful than transrectal biopsy according to both TRANSLATE as well as PREVENT. There's no significant differences in urinary retention and bleeding complications. I think urinary retention was thought to be higher traditionally because transperineal biopsy saturation approach was performed under sedation or general anesthesia.
When we exclude studies that had nonspecific infection definitions, such as telephone calls, prescriptions, and so forth, transperineal has fewer infections than transrectal biopsy, again, per the PREVENT study as well as TRANSLATE, there's mixed results on cancer detection with only TRANSLATE showing a 6% increased detection of clinically significant cancer with transperineal biopsy. And finally, enrollment for PREVENT 2, that is a patient-centered outcomes research institution funded study for prior negative and active surveillance biopsies with the primary outcome of infection is ongoing. Thank you for your attention.