NCT04815876Completed
PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2
Randomized Trial Comparing Transperineal vs. Transrectal MRI-targeted Prostate Biopsy; Randomized Controlled Trial Assessing Transperineal Prostate Biopsy to Reduce Infection Complications
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1040 (actual)
- First submitted
- 22 Mar 2021
- Start date
- 24 Jun 2021
- Primary completion date
- 11 Oct 2025
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Prostate cancer
- NCT number
- NCT04815876
What you commit to
- Study type: Interventional
- Participants enrolled: 1040
- From 24 Jun 2021 to the primary completion date, 11 Oct 2025
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current non-urologic bacterial infection requiring active treatment with antibiotics
- Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation
Other illness
- Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease)
Other
- Acute prostatitis within the last 6 months
- Unfit to undergo prostate biopsy under local anesthesia
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| NewYork-Presbyterian Brooklyn Methodist Hospital Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Einstein Healthcare Network Coordinator of this site? Confirm its status | Elkins Park | United States | Unknown status |
| University of Connecticut Coordinator of this site? Confirm its status | Farmington | United States | Unknown status |
| NewYork-Presbyterian Queens Coordinator of this site? Confirm its status | Flushing | United States | Unknown status |
| University of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Georgetown University Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.