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

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of Southern California
NOT_YET_RECRUITING
Los Angeles
Connecticut
University of Connecticut
RECRUITING
Farmington
Washington, D.c.
Georgetown University
RECRUITING
Washington D.c.
Illinois
Northwestern University
RECRUITING
Chicago
Massachusetts
Beth Israel Deaconess Medical Center
NOT_YET_RECRUITING
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
North Carolina
University of North Carolina
NOT_YET_RECRUITING
Chapel Hill
New York
NewYork-Presbyterian Brooklyn Methodist Hospital
COMPLETED
Brooklyn
NewYork-Presbyterian Queens
RECRUITING
Flushing
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Pennsylvania
Einstein Healthcare Network
RECRUITING
Elkins Park
Fox Chase Cancer Center
RECRUITING
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Dianis Rivera, BS
dir4010@med.cornell.edu
212.746.1496
Backup
Xiaohong Jing, PhD
xij2004@med.cornell.edu
212-746-4739
Time Frame
Start Date: 2021-06-24
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 1302
Treatments
Active_comparator: Transrectal
Patients will receive a transrectal MRI-guided prostate biopsy.
Active_comparator: Transperineal
Patients will receive a transperineal MRI-guided prostate biopsy.
Related Therapeutic Areas
Sponsors
Leads: Weill Medical College of Cornell University
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov