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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
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

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan Medical School
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
Johns Hopkins University
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BaltimoreUnited StatesUnknown status
NewYork-Presbyterian Brooklyn Methodist Hospital
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BrooklynUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesUnknown status
University of Connecticut
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FarmingtonUnited StatesUnknown status
NewYork-Presbyterian Queens
Coordinator of this site? Confirm its status
FlushingUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Weill Cornell Medicine
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Georgetown University
Coordinator of this site? Confirm its status
Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.