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Recruiting Not applicable NCT05155501

Clinical Trial of Approaches to Prostate Cancer Surgery

No applicable phase (e.g. observational)
Conditions: Prostate Cancer

Sponsor: Weill Medical College of Cornell University

trial.available_in: БГ
Overview
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.
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.
Who can participate
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)
Interventions
Robot-assisted radical prostatectomy (RP)
PROCEDURE
Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)
PROCEDURE
Locations 9
United States (9)
Johns Hopkins University
Baltimore , Maryland
Beth Israel Deaconess Medical Center (BIDMC)
Boston , Massachusetts
Northwestern University
Chicago , Illinois
Beckman Research Institute of City of Hope
Duarte , California
Radhika Nagalla, PharmD
NewYork-Presbyterian Queens
Flushing , New York
Hackensack Meridian Health
Hackensack , New Jersey
Memorial Sloan Kettering Cancer Center
New York , New York
Melissa McCarter
Weill Cornell Medicine
New York , New York
Georgetown University
Washington D.C. , District of Columbia
Keith Kowalczyk, MD
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
40 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
15.05.2023
Completion date
01.07.2028
Registry ID
NCT05155501
Source
clinicaltrials.gov
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