RecruitingNot ApplicableNCT05155501

Clinical Trial of Approaches to Prostate Cancer Surgery

Clinical TrIAL of Approaches to Prostate cAncer suRgery

Sponsor

Weill Medical College of Cornell University

Enrollment

600 participants

Start Date

May 15, 2023

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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

Sex: MALEMin Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different surgical approaches for removing the prostate in men with localized prostate cancer (radical prostatectomy). The goal is to understand which approach leads to the best outcomes in terms of cancer control, urinary function, and sexual function. **You may be eligible if...** - You are a male between 40 and 80 years old - You are scheduled to have your prostate surgically removed for localized prostate cancer - You can read and speak English or Spanish - You are willing to consent and follow the study protocol **You may NOT be eligible if...** - You have had major prior pelvic surgery or pelvic radiation therapy - Imaging suggests your cancer may have spread to lymph nodes (any lymph node larger than 1 cm) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERobot-assisted radical prostatectomy (RP)

The conventional approach to prostate cancer surgery

PROCEDUREPelvic 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.