Prospective, Randomized Study Comparing Transperineal and Transrectal Prostate Biopsy Efficacy and Complications (ProBE-PC Trial)
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study evaluates the difference between 2 prostate biopsy methods, transrectal (through the rectal wall) and transperineal (through the skin) needle biopsy. Men who are in need of prostate biopsy due to clinical suspicions of prostate cancer will be randomly assigned (1:1) to either transrectal or transperineal approach. This research study will scientifically determine if one biopsy method is better than the other in reducing complications and improving cancer detection.
Eligibility
Participation Requirements
Sex: Male
Healthy Volunteers: f
View:
• All patients who are scheduled to undergo prostate biopsy for suspected prostate cancer as part of their regular medical care
• Either with or without an MRI
Locations
United States
New York
Albany Medical College
RECRUITING
Albany
Contact Information
Primary
Brenda Romeo, CCRC
amcurologyresearch@amc.edu
518-262-8579
Backup
Badar M Mian
mianb@amc.edu
Time Frame
Start Date: 2019-09-02
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 840
Treatments
Active_comparator: Systematic Transrectal biopsy (TR-Bx)
Ultrasound guided; needle inserted through the rectum to reach the prostate
Active_comparator: Targeted Transrectal biopsy (TR-Bx)
MRI-guided; needle inserted through the rectum to reach the prostate
Experimental: Systematic Transperineal biopsy (TP-Bx)
Ultrasound guided; needle inserted directly through the skin to reach the prostate
Experimental: Targeted Transperineal biopsy (TP-Bx)
MRI-guided; needle inserted directly through the skin to reach the prostate
Related Therapeutic Areas
Sponsors
Leads: Albany Medical College