Prostate Cancer Clinical Trial
Clinical Trial of Approaches to Prostate Cancer Surgery
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.
Full 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.
Eligibility 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)
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There are 4 Locations for this study
Washington District of Columbia, 20007, United States More Info
Principal Investigator
Chicago Illinois, 60611, United States More Info
Principal Investigator
Baltimore Maryland, 21287, United States More Info
Principal Investigator
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