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PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2
Sponsor: Weill Medical College of Cornell University
Summary
Approximately one million transrectal prostate biopsies are performed annually in the U.S., and the risk of post- biopsy infection is increasing due to greater antibiotic resistance of rectal flora. Preliminary data demonstrates that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer. This randomized controlled trial will be the first prospective study to evaluate in-office transperineal MRI targeted prostate biopsy. The investigators hypothesize that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.
Official title: Randomized Trial Comparing Transperineal vs. Transrectal MRI-targeted Prostate Biopsy; Randomized Controlled Trial Assessing Transperineal Prostate Biopsy to Reduce Infection Complications
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1040
Start Date
2021-06-24
Completion Date
2025-10-11
Last Updated
2026-08-24
Healthy Volunteers
No
Conditions
Interventions
Transperineal MRI-guided prostate biopsy
Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.
Transrectal MRI-guided prostate biopsy
Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.
Antibiotic (prophylaxis)
For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA). No antibiotic prophylaxis will be administered for men undergoing transperineal biopsy.
Locations (16)
University of Southern California
Los Angeles, California, United States
University of Connecticut
Farmington, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
NewYork-Presbyterian Queens
Flushing, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Einstein Healthcare Network
Elkins Park, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States