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NCT04815876 · ClinicalTrials.gov registry record · NA
PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2
A NA study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- NA
- Development phase
- 1,030
- Enrollment target
NCT04815876: Completed NA study, sponsored by Weill Medical College of Cornell University.
NCT04815876 is a NA study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 1,030 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04815876, a NA study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,030 participants
- Enrollment target
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.
Primary Outcome
TRUS-BxQ is a validated biopsy questionnaire that measures adverse events that have occurred due to infection. Patient questionnaire consists of Yes/No questions about infection complications and duration of infection.
Interventions
- PROCEDURE Transperineal MRI-guided prostate biopsy
- PROCEDURE Transrectal MRI-guided prostate biopsy
- DRUG Antibiotic (prophylaxis)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,030 participants |
| Start Date | 2021-06-24 |
| Est. Completion | 2025-10-11 |
| Phase | NA |
What the finished NCT04815876 record still lists
NCT04815876 is an interventional study that assigns participants to a tested intervention. Its 1,030 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 3 interventions - of which Transperineal MRI-guided prostate biopsy is the first listed.
NCT04815876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04815876 about?
NCT04815876 is a clinical study titled "PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2". 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 anesthesi...
What is the current status of trial NCT04815876?
This trial is currently completed. It is a NA study. The enrollment target is 1,030 participants. The study started on 2021-06-24. Estimated completion is 2025-10-11.
What interventions are being tested in trial NCT04815876?
The interventions under investigation include: Transperineal MRI-guided prostate biopsy (PROCEDURE), Transrectal MRI-guided prostate biopsy (PROCEDURE), Antibiotic (prophylaxis) (DRUG).
Who is sponsoring clinical trial NCT04815876?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04815876's enrollment target sits among peer trials
1,030 103rd of 2000 higher than 1,897 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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