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Clinical Trial of Approaches to Prostate Cancer Surgery

RECRUITINGN/ASponsored by Weill Medical College of Cornell University
Actively Recruiting
PhaseN/A
SponsorWeill Medical College of Cornell University
Started2023-05-15
Est. completion2026-12
Eligibility
Age40 Years – 80 Years
SexMALE
Healthy vol.Accepted
Locations5 sites

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

Age: 40 Years – 80 YearsSex: MALEHealthy volunteers accepted
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)

Conditions2

CancerProstate Cancer

Locations5 sites

District of Columbia

1 site
Georgetown University
Washington D.C., District of Columbia, 20007
Keith Kowalczyk, MDKeith.Kowalczyk@medstar.net

Illinois

1 site
Northwestern University
Chicago, Illinois, 60611
Mary Kate Keeter, MPH312-694-6082mary.fitzgerald@northwestern.edu

Maryland

1 site
Johns Hopkins University
Baltimore, Maryland, 21287
Rana Harb, MS410-502-5500rharb1@jhmi.edu

New York

2 sites
NewYork-Presbyterian Queens
Flushing, New York, 11355
Neal Patel, MD718-303-3720nap9055@med.cornell.edu
Weill Cornell Medicine
New York, New York, 10065
Jim C Hu, MD MPH646-962-9600jch9011@med.cornell.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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