Robot-Assisted Radical Prostatectomy With or Without Vesicopexy in Patients With Prostate Cancer
NCT04981834 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196
Last updated 2026-01-16
Summary
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.
Conditions
- 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 v8
Interventions
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- OTHER
-
Questionnaire Administration
Ancillary studies
- PROCEDURE
-
Radical Prostatectomy
Undergo RARP
- PROCEDURE
-
Vesicopexy
Undergo vesicopexy
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of Southern California
lead OTHER
Principal Investigators
-
Hooman Djaladat, MD · University of Southern California
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-27
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
Countries
- United States
Study Locations
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