Approximately 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.
We 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.
The 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.
NCT04815876.
BMJ open. 2023 May 19*** epublish ***
Jim Hu, Alec Zhu, Andrew Vickers, Mohamad Ezzeddine Allaf, Behfar Ehdaie, Anthony Schaeffer, Christian Pavlovich, Ashley E Ross, David A Green, Gerald Wang, Serge Ginzburg, Jeffrey S Montgomery, Arvin George, John N Graham, Benjamin T Ristau, Andres Correa, Jonathan E Shoag, Keith J Kowalczyk, Tenny R Zhang, E M Schaeffer
Department of Urology, NewYork-Presbyterian Weill Cornell Medical Center, New York, New York, USA ., Department of Urology, NewYork-Presbyterian Weill Cornell Medical Center, New York, New York, USA., Department of Urology, Memorial Sloan Kettering Cancer Center, New York, New York, USA., Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, Maryland, USA., Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA., Einstein Urology, Albert Einstein Healthcare Network, Philadelphia, Pennsylvania, USA., Department of Urology, University of Michigan Medical School, Ann Arbor, Michigan, USA., Department of Surgery, Division of Urology, University of Connecticut School of Medicine, Farmington, Connecticut, USA., Department of Surgical Oncology, Division of Urology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA., Department of Urology, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA., Department of Urology, MedStar Georgetown University Hospital, Washington, District of Columbia, USA.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/37208135