NCT04843566Completed
PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy
Evaluation of Transperineal Biopsy Under Local Anesthesia, a Novel Approach to Decrease Post-Biopsy Infections and Improve Cancer Detection
Source: ClinicalTrials.gov · Last updated 15 Apr 2025
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
- 687 (actual)
- First submitted
- 10 Apr 2021
- Start date
- 22 Mar 2021
- Primary completion date
- 19 Apr 2024
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Prostate cancer
- NCT number
- NCT04843566
What you commit to
- Study type: Interventional
- Participants enrolled: 687
- From 22 Mar 2021 to the primary completion date, 19 Apr 2024
- 10 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
- PSA \> 20 ng/mL in men who have previously undergone prostate biopsy
- Current non-urologic bacterial infection requiring active treatment with antibiotics
- Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation
- Men who have previously undergone prostate biopsy in whom artifact would reduce quality of prostate MRI (extensive orthopedic pelvic metal)
- Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease) in men who have previously undergone prostate biopsy
Other
- Acute prostatitis within the last 6 months
- Unfit to undergo prostate biopsy under local anesthesia
Who the study is looking for
- Male sex
- Age ≥18 years
- Men without previous prostate biopsy (first time prostate 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 (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Medical School 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 |
| NewYork-Presbyterian Brooklyn Methodist Hospital Coordinator of this site? Confirm its status | Brooklyn | 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 |
| 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 |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | 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.