PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2

Completed · Not applicable

Conditions studied: Infection

In brief

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.

Key facts

Study ID

NCT04815876

Run by

Weill Medical College of Cornell University

People needed

1030

Starts

2021-06-24

Expected to finish

2025-10-11

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Active surveillance cohort: History of Grade Group 1 prostate cancer, first diagnosed ≤24 months prior to date of planned confirmatory biopsy and diagnostic biopsy was preceded by a multiparametric MRI of the prostate
• Prior negative cohort: Clinical concern for the presence of prostate cancer as determined by the treating urologist and prior negative prostate biopsy performed ≤36 months prior to date of planned biopsy
• Willingness to sign informed consent and adhere to the study protocol

You may not qualify if…

• Acute prostatitis within the last 6 months
• Current non-urologic bacterial infection requiring active treatment with antibiotics
• Unfit to undergo prostate biopsy under local anesthesia
• Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation
• Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease)

Where it is running

• 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

Full record on ClinicalTrials.gov

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