Clinical Trial of Approaches to Prostate Cancer Surgery
Status
RECRUITING
Phase
NA
Age
40 - 80 Years
Enrollments
600Conditions
Prostate CancerSummary
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.
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.
Locations
4 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Keith Kowalczyk, MD
- [email protected]
Principal Investigator
- Jim C Hu, MD, MPH
Status
- RECRUITING
Contact Person
- Mary Kate Keeter, MPH
- 312-694-6082
- [email protected]
Principal Investigator
- Jim C Hu, MD, MPH
Status
- RECRUITING
Contact Person
- Rana Harb, MS
- 410-502-5500
- [email protected]
Principal Investigator
- Jim C Hu, MD, MPH
Status
- RECRUITING
Contact Person
- Jim C Hu, MD MPH
- 646-962-9600
- [email protected]
Principal Investigator
- Jim C Hu, MD, MPH
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)
Study Plan
Robot-assisted radical prostatectomy (RP)
ACTIVE_COMPARATOR
The conventional robotic-assisted radical prostatectomy is the gold standard approach to prostate cancer surgery.
PROCEDURE:
Robot-assisted radical prostatectomy (RP)Description:
The conventional approach to prostate cancer surgery
Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)
EXPERIMENTAL
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.
PROCEDURE:
Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)Description:
A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate.
Outcome Measures
Primary Outcome Measures
Surgical Margin Status as assessed by surgical pathology results
Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)
Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)
Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)
Secondary Outcome Measures
Surgery-Related Adverse Events as assessed by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Change in Urinary and Sexual Function, as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
Change in Patient-Reported Penile Shortening and Sexual Function, as measured by a 5-item questionnaire
Change in patient-Reported Penile Curvature/Deformity (Peyronie's Disease), as measured by a 3-item questionnaire
Patient-reported Decision Regret, as measured by a 5-item questionnaire
Patient-reported Decision Regret, as measured by a 5-item questionnaire
Timeline
Last Updated
July 1, 2024Start Date
December 13, 2021Today
February 5, 2025Completion Date ( Estimated )
December 1, 2026
Sponsors of this trial
Lead Sponsor
Weill Medical College of Cornell UniversityCollaborating Sponsors
National Institutes of Health (NIH), National Cancer Institute (NCI)
RECRUITING 
21 - 64 Years