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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Radical Prostatectomy; Procedure: Vesicopexy

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 Type: Interventional
• Enrollment (Anticipated): 196
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ileana Aldana; Phone Number: 323-865-3700; Email: Ileana.Aldana@med.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC / Norris Comprehensive Cancer Center
      • Contact: Ileana Aldana; Phone Number: 323-865-3700; Email: Ileana.Aldana@med.usc.edu
      • Principal Investigator: Hooman Djaladat, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (radical prostatectomy, vesicopexy); 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 Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Radical Prostatectomy; Undergo RARP; Other Names: Prostatovesiculectomy; Procedure: Vesicopexy; Undergo vesicopexy; Other Names: Cystopexy; Vesicofixation
Active Comparator: Arm II (radical prostatectomy); 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 Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Radical Prostatectomy; Undergo RARP; Other Names: Prostatovesiculectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Operative time		Duration of operation
Intra-operative complications		Duration of operation
90-day post-operative complications		90 days post-operative
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

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Hooman Djaladat, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Anticipated): October 27, 2024
• Study Completion (Anticipated): October 27, 2025

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 4P-21-1 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2021-05989 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No