Randomized Trial Results: Transrectal vs Transperitoneal Prostate Biopsy

Educational Objectives

The goal of this program is to improve patient outcomes using transrectal or transperitoneal prostate biopsy. After hearing and assimilating this program, the clinician will be better able to:

1. Explain the findings of the PREVENT and the ProBE-PC trial, which both assessed treatment of BPH.

Summary

Problems and solutions: the transrectal approach for prostate biopsy has been associated with increased risk for infectious complications due to needle passage through the rectum; overuse of antibiotics has led to significant resistance in local bacterial populations; biopsies have resulted in the overdetection and overtreatment of indolent tumors; enhanced antibiotic protocols now include using potent antimicrobials and conducting rectal swab cultures to identify resistant bacteria, allowing for targeted antibiotic therapy; betadine enemas are used to antiseptically clean the rectal area before the biopsy

American Urological Association Quality Improvement Summit 2014 recommendations: practices should establish and consistently follow biopsy protocols, and regularly report infection rates; use local antibiograms for antibiotic prescriptions, as local resistance patterns can vary; identify high-risk patients, such as those with recent antimicrobial use, international travel, or prior biopsies; use rectal swabs or augmented antibiotics, particularly for high-risk patients, to enhance safety and reduce infection rates

Caveats: using augmented prophylaxis for prostate biopsies may contribute to increased resistance; rectal swabs are logistically challenging for many practices and may still necessitate the use of strong antibiotics for some patients; active surveillance for very low- and low-risk prostate cancer often requires repeat biopsies, which may miss tumors, particularly those in the anterior region; this area is harder to target with transrectal biopsies, especially in patients of African ancestry, where such tumors are more prevalent

Transperineal template biopsies: involve using a brachytherapy grid to systematically sample the prostate, typically requiring general anesthesia due to the multiple needle insertions through the perineum; this method was mainly used for saturation biopsies, aimed at obtaining extensive tissue samples

In-office transperineal biopsy with local anesthesia: this method uses a disposable device that allows for precise needle placement, enabling biopsies from various angles based on the needle aperture selected; patients are positioned in the lithotomy position, and the scrotum is retracted to expose the perineum; a single needle puncture on each side of the perineum is used for sampling

Benefits: uses local anesthesia and enables targeted sampling; this approach focuses solely on the peripheral zone, potentially improving the quality of cores; however, it requires specialized infrastructure, side-fire ultrasonography probe

PREVENT randomized trial (Hu et al [2024]): aimed to compare in-office transperineal and transrectal magnetic resonance imaging-guided biopsies in biopsy-naive patients; key objectives included evaluating differences in adverse events (infection rates, bleeding complications, and urinary retention), pain and discomfort levels, and cancer detection rates; patients with PI-RADS 3, 4, or 5 lesions, who underwent biopsies with fusion or cognitive fusion modalities, were included

Results and conclusion: transperineal biopsies, performed with no antibiotics but with perineal cleansing using chlorhexidine, resulted in zero infections; transrectal biopsies, which included preprocedural antimicrobials and rectal swabs, saw 4 infections; however, the difference was not statistically significant; there was 1 case of urinary retention in the transperineal group and 3 cases in the transrectal group, also not significant; bleeding complications were noted in one transrectal biopsy patient, requiring intervention, whereas there were no such complications in the transperineal group; detection rates for clinically significant cancers were similar for both biopsy approaches; pain scores with the transperineal procedure were slightly higher but quickly normalized, matching those of the transrectal biopsy; overall, transperineal biopsy had comparable safety and efficacy to the transrectal approach, with no notable differences

Comparison of ProBE-PC trial (Mian et al [2024]) and the PREVENT trial: the ProBE-PC trial included a higher proportion of White patients compared with the PREVENT trial; while the PREVENT trial focused on first-time biopsy patients, the ProBE-PC trial included patients undergoing second and third biopsies; the PREVENT trial was conducted by a larger team of 24 urologists, in contrast to the 3 urologists involved in the ProBE-PC trial; the infection rate reported in the ProBE-PC trial for transperineal biopsies was 2.7%, whereas the PREVENT trial reported a 0% infection rate with transperineal biopsies; despite these differences, both trials are considered negative, as they did not demonstrate a clear advantage of one biopsy method over the other

Readings

Chung Y, Hong SK. Shifting to transperineal prostate biopsy: A narrative review. Prostate Int. 2024;12(1):10-14. doi:10.1016/j.prnil.2023.11.003; Grummet JP, Weerakoon M, Huang S, et al. Sepsis and 'superbugs': Should we favour the transperineal over the transrectal approach for prostate biopsy? BJU Int. 2014;114(3):384-388. doi:10.1111/bju.12536; Hu JC, Assel M, Allaf ME, et al. Transperineal versus transrectal magnetic resonance imaging-targeted and systematic prostate biopsy to prevent infectious complications: The PREVENT randomized trial. Eur Urol. 2024;86(1):61-68. doi:10.1016/j.eururo.2023.12.015; Huang GL, Kang CH, Lee WC, et al. Comparisons of cancer detection rate and complications between transrectal and transperineal prostate biopsy approaches - a single center preliminary study. BMC Urol. 2019;19(1):101. doi:10.1186/s12894-019-0539-4; Mian BM, Feustel PJ, Aziz A, et al. Complications following transrectal and transperineal prostate biopsy: Results of the ProBE-PC randomized clinical trial. J Urol. 2024;211(2):205-213. doi:10.1097/JU.0000000000003788; Mian BM, Feustel PJ, Aziz A, et al. Clinically significant prostate cancer detection following transrectal and transperineal biopsy: Results of the prostate biopsy efficacy and complications randomized clinical trial. J Urol. 2024;212(1):21-31. doi:10.1097/JU.0000000000003979; Rai BP, Mayerhofer C, Somani BK, et al. Magnetic resonance imaging/ultrasound fusion-guided transperineal versus magnetic resonance imaging/ultrasound fusion-guided transrectal prostate biopsy - a systematic review. Eur Urol Oncol. 2021;4(6):904-913. doi:10.1016/j.euo.2020.12.012.

Disclosures

For this program, the following relevant financial relationships were disclosed and mitigated to ensure that no commercial bias has been inserted into this content: Dr. Allaf reported nothing relevant to disclose. Members of the planning committee reported nothing relevant to disclose. Dr. Allaf's lecture includes information related to the off-label or investigational use of a therapy, product, or device.

Acknowledgements

Dr. Allaf was recorded at the 43rd Annual Ralph E. Hopkins Urology Seminar, held January 31 to February 3, 2024, in Jackson Hole, WY, and presented by Grand Rounds in Urology. For information on upcoming CME activities from this presenter, please visit Jacksonholeseminars.com. Audio Digest thanks the speakers and Grand Rounds in Urology for their cooperation in the production of this program.

CME/CE INFO

Accreditation:

The Audio- Digest Foundation is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Audio- Digest Foundation designates this enduring material for a maximum of 0.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Audio Digest Foundation is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's (ANCC's) Commission on Accreditation. Audio Digest Foundation designates this activity for 0.75 CE contact hours.

Lecture ID:

UR471904

Expiration:

This CME course qualifies for AMA PRA Category 1 Credits™ for 3 years from the date of publication.

Instructions:

To earn CME/CE credit for this course, you must complete all the following components in the order recommended: (1) Review introductory course content, including Educational Objectives and Faculty/Planner Disclosures; (2) Listen to the audio program and review accompanying learning materials; (3) Complete posttest (only after completing Step 2) and earn a passing score of at least 80%. Taking the course Pretest and completing the Evaluation Survey are strongly recommended (but not mandatory) components of completing this CME/CE course.

Estimated time to complete this CME/CE course:

Approximately 2x the length of the recorded lecture to account for time spent studying accompanying learning materials and completing tests.