Protocol of a multicentre randomised controlled trial assessing transperineal prostate biopsy to reduce infectiouscomplications

Abstract

IntroductionApproximately one million prostate biopsies are performed annually in the USA, and most are performed using a transrectal approach under local anaesthesia. The risk of postbiopsy infection is increasing due to increasing antibiotic resistance of rectal flora. Single-centre studies suggest that a clean, percutaneous transperineal approach to prostate biopsy may have a lower risk of infection. To date, there is no high-level evidence comparing transperineal versus transrectal prostate biopsy. We hypothesise that transperineal versus transrectal prostate biopsy under local anaesthesia has a significantly lower risk of infection, similar pain/discomfort levels and comparable detection of non-low-grade prostate cancer.Methods and analysisWe will perform a multicentre, prospective randomised clinical trial to compare transperineal versus transrectal prostate biopsy for elevated prostate-specific antigen in the first biopsy, prior negative biopsy and active surveillance biopsy setting. Prostate MRI will be performed prior to biopsy, and targeted biopsy will be conducted for suspicious MRI lesions in addition to systematic biopsy (12 cores). Approximately 1700 men will be recruited and randomised in a 1:1 ratio to transperineal versus transrectal biopsy. A streamlined design to collect data and to determine trial eligibility along with the two-stage consent process will be used to facilitate subject recruitment and retention. The primary outcome is postbiopsy infection, and secondary outcomes include other adverse events (bleeding, urinary retention), pain/discomfort/anxiety and critically, detection of non-low-grade (grade group ≥2) prostate cancer.Ethics and disseminationThe Institutional Review Board of the Biomedical Research Alliance of New York approved the research protocol (protocol number #18-02-365, approved 20 April 2020). The results of the trial will be presented at scientific conferences and published in peer-reviewed medical journals.Trial registration numberNCT04815876.

Letter: Complications Following Transrectal and Transperineal Prostate Biopsy: Results of the ProBE-PC Randomized Clinical Trial

“…Fortunately, an RCT that aligns with the outcome measurements, specifically UTI and urosepsis, is currently underway. 4 The excellent results of this study, along with future research, are likely to further the understanding of the clinical safety of both the TP and TR approaches.…”

Perspectives on technology – prostate cancer: is local anaesthetic transperineal prostate biopsy really better than transrectal biopsy?

“…A large RCT from Weill Cornell Medical Center, New York is recruiting 1700 patients to compare LATP to TRUS biopsy [19]. Working with PCORI, the study protocol combines two separately registered trials, PREVENT and PREVENT2 [20,21].…”

Reply: Complications Following Transrectal and Transperineal Prostate Biopsy: Results of the ProBE-PC Randomized Clinical Trial

“…The letter refers to an infectious advantage to TP-Bx (over TR-Bx), yet no such advantage has been demonstrated by any level 1 evidence from our and other trials. 4 The authors suggest a potential increased burden and cost of antibiotic prophylaxis, but mere inference is insufficient, and this should be elaborated and specifically studied. In conducting a holistic assessment of comparative effectiveness of these procedures, it’s important to include all costs and burdens of the procedures and not selectively focus on one aspect alone.…”