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

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

Inclusion Criteria5

  • 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 Criteria2

  • Prior major pelvic surgery or radiotherapy
  • Suspicion of N1 disease (i.e., any lymph node greater than 1cm in maximal diameter)

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.


Locations(5)

Georgetown University

Washington D.C., District of Columbia, United States

Northwestern University

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

NewYork-Presbyterian Queens

Flushing, New York, United States

Weill Cornell Medicine

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05155501


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