Clinical Trial of Approaches to Prostate Cancer Surgery

Recruiting now · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05155501

Run by

Weill Medical College of Cornell University

People needed

600

Starts

2023-05-15

Expected to finish

2028-07-01

Last updated by the study team

2026-04-22

Who can join

Age: 40 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Beckman Research Institute of City of Hope — Duarte, California, United States (enrolling)
• Georgetown University — Washington D.C., District of Columbia, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Beth Israel Deaconess Medical Center (BIDMC) — Boston, Massachusetts, United States (enrolling)
• Hackensack Meridian Health — Hackensack, New Jersey, United States (enrolling)
• NewYork-Presbyterian Queens — Flushing, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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