RECRUITING
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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 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.
Conditions:
🦠 Infection
🗓️ Study Start (Actual) 24 June 2021
🗓️ Primary Completion (Estimated) 1 June 2025
✅ Study Completion (Estimated) 1 June 2025
👥 Enrollment (Estimated) 1302
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Los Angeles, California, United States
📍 Farmington, Connecticut, United States
📍 Washington, District of Columbia, United States
📍 Chicago, Illinois, United States
📍 Baltimore, Maryland, United States
📍 Boston, Massachusetts, United States
📍 Boston, Massachusetts, United States
📍 Ann Arbor, Michigan, United States
📍 Brooklyn, New York, United States
📍 Flushing, New York, United States
📍 New York, New York, United States
📍 Chapel Hill, North Carolina, United States
📍 Cleveland, Ohio, United States
📍 Elkins Park, Pennsylvania, United States
📍 Philadelphia, Pennsylvania, United States
📍 Philadelphia, Pennsylvania, United States
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * Acute prostatitis within the last 6 months
    • * Current non-urologic bacterial infection requiring active treatment with antibiotics
    • * Unfit to undergo prostate biopsy under local anesthesia
    • * Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation
    • * Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 22 March 2021
  • First Submitted that Met QC Criteria 22 March 2021
  • First Posted 25 March 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 April 2024
  • Last Update Posted 12 April 2024
  • Last Verified April 2024
I'm interested ...!!