Clinical Trial of Approaches to Prostate Cancer Surgery
Purpose
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
- Prostate Cancer
Eligibility
- Eligible Ages
- Between 40 Years and 80 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Outcomes assessors (i.e., pathologists) will be blinded to randomization.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Robot-assisted radical prostatectomy (RP) |
The conventional robotic-assisted radical prostatectomy is the gold standard approach to prostate cancer surgery. |
|
|
Experimental Pelvic 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. These structures are disrupted and removed during conventional radical prostatectomy. |
|
Recruiting Locations
Washington, District of Columbia 20007
More Details
- Status
- Recruiting
- Sponsor
- Weill Medical College of Cornell University
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.