Clinical Trial of Approaches to Prostate Cancer Surgery
Recruiting · NCT05155501 · Interventional (participants receive a specific treatment) · Lead sponsor: Weill Medical College of Cornell University
View the official record on ClinicalTrials.gov →Interventions studied
Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)Robot-assisted radical prostatectomy (RP)
What this trial is about
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.
Who can take part
Age range
40 Years to 80 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- Prior major pelvic surgery or radiotherapy
- Suspicion of N1 disease (i.e., any lymph node greater than 1cm in maximal diameter)
Where it is running
9 locations listed across 7 US states.
- Beckman Research Institute of City of Hope - Duarte, California, United States
- Georgetown University - Washington D.C., District of Columbia, United States
- Northwestern University - Chicago, Illinois, United States
- Johns Hopkins University - Baltimore, Maryland, United States
- Beth Israel Deaconess Medical Center (BIDMC) - Boston, Massachusetts, United States
- Hackensack Meridian Health - Hackensack, New Jersey, United States
- NewYork-Presbyterian Queens - Flushing, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Weill Cornell Medicine - New York, New York, United States