Clinical TrIAL of Approaches to Prostate cAncer suRgery
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:
• Male sex
• Age ≥40 years or ≤80 years
• Scheduled for radical prostatectomy for clinically localized prostate cancer
• Able to read and speak English or Spanish
• Willingness to sign informed consent and adhere to the study protocol
Locations
United States
Washington, D.c.
Georgetown University
RECRUITING
Washington D.c.
Illinois
Northwestern University
RECRUITING
Chicago
Maryland
Johns Hopkins University
RECRUITING
Baltimore
New York
NewYork-Presbyterian Queens
RECRUITING
Flushing
Weill Cornell Medicine
RECRUITING
New York
Contact Information
Primary
May Ting, MBS
mat7051@med.cornell.edu
732-757-2448
Backup
Xiaohong Jing, PhD
xij2004@med.cornell.edu
212-746-4739
Time Frame
Start Date: 2023-05-15
Estimated Completion Date: 2026-12
Participants
Target number of participants: 600
Treatments
Active_comparator: Robot-assisted radical prostatectomy (RP)
The conventional robotic-assisted radical prostatectomy is the gold standard approach to prostate cancer surgery.
Experimental: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)
A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate. These structures are disrupted and removed during conventional radical prostatectomy.
Authors
Related Therapeutic Areas
Sponsors
Leads: Weill Medical College of Cornell University
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)