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

NCT04981834 | Suspended DMC

• 3 other identifiers: 4P-21-1NCI-2021-05989P30CA014089
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

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; Stage I Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 3-month (+/- 3 weeks) quality of life following surgery

  3 months post-operative

• 72-hour postop urinary continence following surgery

  72 hours post-operative

• 1-month (+/- 1 week) post-operative urinary continence following surgery

  1 month post-operative

• Sexual function at 3-month (+/- 3 weeks) following surgery

  3 months post-operative

• Operative time

  Duration of operation

Study Arms (2)

Arm I (radical prostatectomy, vesicopexy)

EXPERIMENTAL

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; Other: Questionnaire Administration; Procedure: Radical Prostatectomy; Procedure: Vesicopexy

Arm II (radical prostatectomy)

ACTIVE COMPARATOR

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; Other: Questionnaire Administration; Procedure: Radical Prostatectomy

Interventions

Questionnaire Administration OTHER

Ancillary studies

Arm I (radical prostatectomy, vesicopexy); Arm II (radical prostatectomy)

Radical Prostatectomy PROCEDURE

Undergo RARP

Also known as: Prostatovesiculectomy

Arm I (radical prostatectomy, vesicopexy); Arm II (radical prostatectomy)

Vesicopexy PROCEDURE

Undergo vesicopexy

Also known as: Cystopexy, Vesicofixation

Arm I (radical prostatectomy, vesicopexy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (radical prostatectomy, vesicopexy); Arm II (radical prostatectomy)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Hooman Djaladat, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: July 29, 2021
• Study Start: October 27, 2021
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)