Transperineal vs. Transrectal MRI-targeted Prostate Biopsy

• Status: Recruiting
• Trial end date: 2025-04-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Patient-Centered Outcomes Research Institute
• Treatments: Anti-Bacterial Agents

Criteria

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)