Clinical Trial of Approaches to Prostate Cancer Surgery
Start Date
5/15/2023
Completion Date
7/1/2028
Summary
This is a prospective, randomized controlled trial to compare cancer control and health-related quality of life following pelvic fascia-sparing radical prostatectomy versus standard radical prostatectomy. The investigators hypothesize that pelvic fascia-sparing radical prostatectomy will have similar cancer control (primary outcome) and sexual function outcomes; and significantly better urinary function, penile shortening/deformity and inguinal hernia risks as compared to radical prostatectomy.
Detailed Description
Traditional radical prostatectomy is the most popular treatment for clinically significant prostate cancer, however significant risks including urinary incontinence, erectile dysfunction, penile shortening, penile curvature/ deformation (Peyronie's disease), and inguinal hernia, are common. Pelvic fascia-sparing radical prostatectomy is a new surgical technique that may preserve fascial support structures, arterial supply to the penis, and nerves that are severed and resected during conventional radical prostatectomy. This study will enroll adult men undergoing radical prostatectomy for clinically localized prostate cancer. Subjects will be randomized to receive either radical prostatectomy or pelvic fascia-sparing radical prostatectomy. Investigators will compare cancer control and health-related quality of life outcomes through patient questionnaires and medical record review.
Eligibility Criteria
Age Range: 40 years to 80 years
Interventions
Robot-assisted radical prostatectomy (RP)
Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)
Conditions
Locations
Beckman Research Institute of City of Hope
Duarte, California 91010
United States
Georgetown University
Washington D.C., District of Columbia 20007
United States
Northwestern University
Chicago, Illinois 60611
United States
Johns Hopkins University
Baltimore, Maryland 21287
United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts 02215
United States
Hackensack Meridian Health
Hackensack, New Jersey 07601
United States
NewYork-Presbyterian Queens
Flushing, New York 11355
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Weill Cornell Medicine
New York, New York 10065
United States