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NCT05155501NARecruiting

Clinical Trial of Approaches to Prostate Cancer Surgery

Weill Medical College of Cornell University

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

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

PROCEDURE

Robot-assisted radical prostatectomy (RP)

PROCEDURE

Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)

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Conditions

Prostate Cancer

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