Evaluation of Transperineal Biopsy Under Local Anesthesia, a Novel Approach to Decrease Post-Biopsy Infections and Improve Cancer Detection

Status: Completed
Location: See all (10) 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:

• Male sex

• Age ≥18 years

• Men without previous prostate biopsy (first time prostate biopsy)

• Willingness to sign informed consent and adhere to the study protocol

Locations
United States
Connecticut
University of Connecticut
Farmington
Washington, D.c.
Georgetown University
Washington
Illinois
Northwestern University
Chicago
Maryland
Johns Hopkins University
Baltimore
Michigan
University of Michigan Medical School
Ann Arbor
New York
NewYork Presbyterian Brooklyn Methodist Hospital
Brooklyn
NewYork-Presbyterian Queens
Flushing
Memorial Sloan Kettering Cancer Center
New York
Weill Cornell Medicine
New York
Ohio
University Hospitals Cleveland Medical Center
Cleveland
Time Frame
Start Date: 2021-03-22
Completion Date: 2024-04-19
Participants
Target number of participants: 738
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.
Sponsors
Leads: Weill Medical College of Cornell University
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov