Robot-Assisted Radical Prostatectomy With or Without Vesicopexy in Patients With Prostate Cancer

Not Applicable

Recruiting

• Conditions: Stage II Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8; Stage I 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
• Interventions: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Radical Prostatectomy; Procedure: Vesicopexy

• Registration Number: NCT04981834
• Lead Sponsor: University of Southern California

Brief 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.

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.

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-07-29
• Study Start: 2021-10-27
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-24
• Primary Completion: 2025-10-27
• Study Completion: 2026-10-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 196

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (radical prostatectomy, vesicopexy)	Questionnaire Administration	Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
Arm I (radical prostatectomy, vesicopexy)	Vesicopexy	Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
Arm II (radical prostatectomy)	Questionnaire Administration	Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
Arm II (radical prostatectomy)	Radical Prostatectomy	Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
Arm I (radical prostatectomy, vesicopexy)	Radical Prostatectomy	Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
Arm I (radical prostatectomy, vesicopexy)	Quality-of-Life Assessment	Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
Arm II (radical prostatectomy)	Quality-of-Life Assessment	Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.

Primary Outcome Measures

Name	Time	Method
3-month (+/- 3 weeks) urinary continence rate following RARP with or without vesicopexy	3 months post-operative	Defined continence as 0-1 safety pad usage. Use the "pictorial pad usage questionnaire."

Secondary Outcome Measures

Name	Time	Method
72-hour postop urinary continence following surgery	72 hours post-operative	Defined continence as 0-1 safety pad usage. Assessed with the "pictorial pad usage questionnaire."
90-day post-operative complications	90 days post-operative
Operative time	Duration of operation
1-month (+/- 1 week) post-operative urinary continence following surgery	1 month post-operative	Defined continence as 0-1 safety pad usage. Assessed with the "pictorial pad usage questionnaire."
3-month (+/- 3 weeks) quality of life following surgery	3 months post-operative	Use the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ-PR25).
Sexual function at 3-month (+/- 3 weeks) following surgery	3 months post-operative	Sexual Health Inventory for Men (SHIM) questionnaire is used for the evaluation of sexual function.
Intra-operative complications	Duration of operation

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States