PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2
Public ClinicalTrials.gov record NCT04815876. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized Trial Comparing Transperineal vs. Transrectal MRI-targeted Prostate Biopsy; Randomized Controlled Trial Assessing Transperineal Prostate Biopsy to Reduce Infection Complications
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04815876
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,040 participants
Conditions and interventions
Conditions
Interventions
- Transperineal MRI-guided prostate biopsy Procedure
- Transrectal MRI-guided prostate biopsy Procedure
- Antibiotic (prophylaxis) Drug
Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 23, 2021
- Primary completion
- Oct 10, 2025
- Completion
- Oct 10, 2025
- Last update posted
- Aug 23, 2026
2021 – 2025
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | — |
| University of Connecticut | Farmington | Connecticut | 06030 | — |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| NewYork-Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York | 11217 | — |
| NewYork-Presbyterian Queens | Flushing | New York | 11355 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Einstein Healthcare Network | Elkins Park | Pennsylvania | 19027 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04815876, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 23, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04815876 live on ClinicalTrials.gov.