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PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2

NCT04815876 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1030

Last updated 2026-02-20

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Jim C Hu, MD MPH · Weill Cornell Medicine, NewYork-Presbyterian

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-24
Primary Completion
2025-10-11
Completion
2025-10-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04815876 on ClinicalTrials.gov