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

Stage III Prostate Cancer AJCC v8 Clinical Trial

Official title:

The Effect of Vesicopexy on Urinary Continence and Quality of Life Following Robotic-Assisted Radical Prostatectomy: A Phase III Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04981834
• Other study ID #: 4P-21-1
• Secondary ID: NCI-2021-059894P
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2021
• Est. completion date: October 27, 2026

Study information

• Verified date: May 2024
• Source: University of Southern California
• Contact: Ileana Aldana
• Phone: 323-865-3700
• Email: Ileana.aldana[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: October 27, 2026
• Est. primary completion date: October 27, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• 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

Intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Procedure:
• Radical Prostatectomy
Undergo RARP
• Vesicopexy
Undergo vesicopexy

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-month (+/- 3 weeks) urinary continence rate following RARP with or without vesicopexy	Defined continence as 0-1 safety pad usage. Use the "pictorial pad usage questionnaire."	3 months post-operative
Secondary	3-month (+/- 3 weeks) quality of life following surgery	Use the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ-PR25).	3 months post-operative
Secondary	72-hour postop urinary continence following surgery	Defined continence as 0-1 safety pad usage. Assessed with the "pictorial pad usage questionnaire."	72 hours post-operative
Secondary	1-month (+/- 1 week) post-operative urinary continence following surgery	Defined continence as 0-1 safety pad usage. Assessed with the "pictorial pad usage questionnaire."	1 month post-operative
Secondary	Sexual function at 3-month (+/- 3 weeks) following surgery	Sexual Health Inventory for Men (SHIM) questionnaire is used for the evaluation of sexual function.	3 months post-operative
Secondary	Operative time		Duration of operation
Secondary	Intra-operative complications		Duration of operation
Secondary	90-day post-operative complications		90 days post-operative