Evaluation of Transperineal Biopsy Under Local Anesthesia - Trial NCT04843566
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Study Focus
Sponsor & Location
Weill Medical College of Cornell University
Timeline & Enrollment
N/A
Mar 22, 2021
Jun 01, 2025
Primary Outcome
Change in infection adverse events, as measured on Transrectal Ultrasound Guided prostate Biopsy Questionnaire (TRUS-BxQ)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04843566
Non-Device Trial