Robot-Assisted Radical Prostatectomy With or Without Vesicopexy in Patients With Prostate Cancer
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Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT04981834
- Run by
- University of Southern California
- People needed
- 196
- Starts
- 2021-10-27
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2026-06-01
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- Any history of psychiatric, neurologic or cognitive disease
- Any history of neuropathic bladder
- Any drug or alcohol addiction
Where it is running
- USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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