Robot-Assisted Radical Prostatectomy With or Without Vesicopexy in Patients With Prostate Cancer
Status
RECRUITING
Phase
NA
Age
≥ 18 Years
Enrollments
196Conditions
Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8Summary
This phase III trial compares the effects of robot-assisted radical prostatectomy (RARP) with or without vesicopexy on urinary continence (a person's ability to control their bladder) and quality of life in patients with cancer of the prostate. RARP is the most adopted surgical approach for treatment of prostate cancer that has not spread to other places in the body (non-metastatic). Urinary incontinence (inability to control the bladder) is one of the most common complications of RARP, impacting patients' quality of life and psychological well-being. Different techniques have been proposed to improve urinary continence following RARP. Vesicopexy is one technique that restores the bladder to its normal position in the body after RARP. This study aims to evaluate whether RARP with vesicopexy may improve urinary continence and quality of life after surgery in prostate cancer patients.
Detailed Description
PRIMARY OBJECTIVE:
I. To determine the 3-month (+/- 3 weeks) urinary continence following RARP with or without vesicopexy.
SECONDARY OBJECTIVES:
I. To evaluate the 3-month (+/- 3 weeks) quality of life following RARP with or without vesicopexy.
II. To evaluate the 72-hour post-operative (postop) urinary continence following RARP with or without vesicopexy.
III. To evaluate the 1-month (+/- 1 week) postop urinary continence following RARP with or without vesicopexy.
IV. To evaluate sexual function at 3-month (+/- 3 weeks) following RARP with or without vesicopexy.
V. To evaluate the operative time in patients undergoing RARP with or without vesicopexy.
VI. To evaluate intraoperative complications in patients undergoing RARP with or without vesicopexy.
VII. To evaluate 90-day post-operative complications in patients undergoing RARP with or without vesicopexy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
ARM II: Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
After study completion, patients will be followed-up with at 24 hours, 1-month, and 3-months.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Ileana Aldana
- 323-865-3700
- [email protected]
Principal Investigator
- Hooman Djaladat, MD
Eligibility Criteria
Inclusion Criteria:
* Men with age > 18 years
* Prostate cancer patients undergoing RARP with anterior approach at University of Southern California (USC) urology
* Ability to understand and the willingness to sign a written informed consent
* Clinical stage < 4 and (M0) prostate cancer
* Eastern Cooperative Oncology Group (ECOG) performance score 0-1
* Pre-operative (op) urinary continence
* Negative history of pelvic radiation and/or previous local therapy for prostate cancer (i.e., radiation or focal therapy)
Exclusion Criteria:
* Any history of psychiatric, neurologic or cognitive disease
* Any history of neuropathic bladder
* Any drug or alcohol addiction
Study Plan
Arm I (radical prostatectomy, vesicopexy)
EXPERIMENTAL
Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
OTHER:
Quality-of-Life AssessmentDescription:
Ancillary studiesOTHER:
Questionnaire AdministrationDescription:
Ancillary studiesPROCEDURE:
Radical ProstatectomyDescription:
Undergo RARPPROCEDURE:
VesicopexyDescription:
Undergo vesicopexy
Arm II (radical prostatectomy)
ACTIVE_COMPARATOR
Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
OTHER:
Quality-of-Life AssessmentDescription:
Ancillary studiesOTHER:
Questionnaire AdministrationDescription:
Ancillary studiesPROCEDURE:
Radical ProstatectomyDescription:
Undergo RARP
Outcome Measures
Primary Outcome Measures
3-month (+/- 3 weeks) urinary continence rate following RARP with or without vesicopexy
Secondary Outcome Measures
3-month (+/- 3 weeks) quality of life following surgery
72-hour postop urinary continence following surgery
1-month (+/- 1 week) post-operative urinary continence following surgery
Sexual function at 3-month (+/- 3 weeks) following surgery
Operative time
Intra-operative complications
90-day post-operative complications
Timeline
Last Updated
May 24, 2024Start Date
July 29, 2021Today
January 16, 2025Completion Date ( Estimated )
October 27, 2026
Sponsors of this trial
Lead Sponsor
University of Southern CaliforniaCollaborating Sponsors
National Cancer Institute (NCI)
RECRUITING 
21 - 64 Years