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NCT05155501 | RECRUITING | Prostate Cancer

Clinical Trial of Approaches to Prostate Cancer Surgery
Sponsor:

Weill Medical College of Cornell University

Brief 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.

Condition or disease

Prostate Cancer

Intervention/treatment

Robot-assisted radical prostatectomy (RP)

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

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 600 participants
Masking : SINGLE
Masking Description : Outcomes assessors (i.e., pathologists) will be blinded to randomization.
Primary Purpose : TREATMENT
Official Title : Clinical TrIAL of Approaches to Prostate cAncer suRgery
Actual Study Start Date : 2023-05-15
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
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)
Clinical Trial of Approaches to Prostate Cancer Surgery

Location Details

NCT05155501

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, District of Columbia

Georgetown University

Washington, District of Columbia, United States, 20007

RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RECRUITING

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21287

RECRUITING

United States, New York

NewYork-Presbyterian Queens

Flushing, New York, United States, 11355

RECRUITING

United States, New York

Weill Cornell Medicine

New York, New York, United States, 10065