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NCT04843566 · ClinicalTrials.gov registry record · NA
PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy
A NA study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- NA
- Development phase
- 687
- Enrollment target
NCT04843566: Completed NA study, sponsored by Weill Medical College of Cornell University.
NCT04843566 is a NA study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 687 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04843566, a NA study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- NA
- Development phase
- 687 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
Outcome measure Description Now says: Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ) is a validated biopsy questionnaire that measures adverse events that have occurred due to infection. Patient questionnaires that reported infection complications and duration of symptoms, had their electronic medical records verified to confirm if an infection occurred or not.
Interventions
- PROCEDURE Transperineal MRI-guided prostate biopsy
- PROCEDURE Transrectal MRI-guided prostate biopsy
- DRUG Antibiotic (prophylaxis)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 687 participants |
| Start Date | 2021-03-22 |
| Est. Completion | 2024-04-19 |
| Phase | NA |
What the finished NCT04843566 record still lists
NCT04843566 is an interventional study that assigns participants to a tested intervention. The registered 687 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 3 interventions - of which Transperineal MRI-guided prostate biopsy is the first listed.
NCT04843566 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04843566 about?
NCT04843566 is a clinical study titled "PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy". 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 NCT04843566?
This trial is currently completed. It is a NA study. The enrollment target is 687 participants. The study started on 2021-03-22. Estimated completion is 2024-04-19.
What interventions are being tested in trial NCT04843566?
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 NCT04843566?
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 NCT04843566's enrollment target sits among peer trials
687 151st of 2000 higher than 1,850 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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