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NCT04815876Completed

PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy 2

Randomized Trial Comparing Transperineal vs. Transrectal MRI-targeted Prostate Biopsy; Randomized Controlled Trial Assessing Transperineal Prostate Biopsy to Reduce Infection Complications

Source: ClinicalTrials.gov · Last updated 24 Aug 2026

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
1040 (actual)
First submitted
22 Mar 2021
Start date
24 Jun 2021
Primary completion date
11 Oct 2025
Lead sponsor
Weill Medical College of Cornell University
NCT number
NCT04815876

What you commit to

  • Study type: Interventional
  • Participants enrolled: 1040
  • From 24 Jun 2021 to the primary completion date, 11 Oct 2025
  • 16 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

  • Current non-urologic bacterial infection requiring active treatment with antibiotics
  • Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation

Other illness

  • Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease)

Other

  • Acute prostatitis within the last 6 months
  • Unfit to undergo prostate biopsy under local anesthesia

Who the study is looking for

  • Active surveillance cohort: History of Grade Group 1 prostate cancer, first diagnosed ≤24 months prior to date of planned confirmatory biopsy and diagnostic biopsy was preceded by a multiparametric MRI of the prostate
  • Prior negative cohort: Clinical concern for the presence of prostate cancer as determined by the treating urologist and prior negative prostate biopsy performed ≤36 months prior to date of planned 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 (16)

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

SiteCityCountrySite status
University of Michigan
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Ann ArborUnited StatesUnknown status
Johns Hopkins University
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BaltimoreUnited StatesUnknown status
Beth Israel Deaconess Medical Center
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BostonUnited StatesUnknown status
Brigham and Women's Hospital
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BostonUnited StatesUnknown status
NewYork-Presbyterian Brooklyn Methodist Hospital
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BrooklynUnited StatesUnknown status
University of North Carolina
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Chapel HillUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
University Hospitals Cleveland Medical Center*
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ClevelandUnited StatesUnknown status
Einstein Healthcare Network
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Elkins ParkUnited StatesUnknown status
University of Connecticut
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FarmingtonUnited StatesUnknown status
NewYork-Presbyterian Queens
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FlushingUnited StatesUnknown status
University of Southern California
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Los AngelesUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
Fox Chase Cancer Center
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PhiladelphiaUnited StatesUnknown status
Georgetown University
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Washington D.C.United StatesUnknown status

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