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COMPLETED
NCT04815876
NA

PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

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

PROCEDURE

Transperineal MRI-guided prostate biopsy

Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.

PROCEDURE

Transrectal MRI-guided prostate biopsy

Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.

DRUG

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