SUSPENDED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-27
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT04981834

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men with age \> 18 years
  2. * Prostate cancer patients undergoing RARP with anterior approach at University of Southern California (USC) urology
  3. * Ability to understand and the willingness to sign a written informed consent
  4. * Clinical stage \< 4 and (M0) prostate cancer
  5. * Eastern Cooperative Oncology Group (ECOG) performance score 0-1
  6. * Pre-operative (op) urinary continence
  7. * Negative history of pelvic radiation and/or previous local therapy for prostate cancer (i.e., radiation or focal therapy)
  1. * Any history of psychiatric, neurologic or cognitive disease
  2. * Any history of neuropathic bladder
  3. * Any drug or alcohol addiction

Contacts and Locations

Principal Investigator

Hooman Djaladat, MD
PRINCIPAL_INVESTIGATOR
University of Southern California

Study Locations (Sites)

USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States

Collaborators and Investigators

Sponsor: University of Southern California

  • Hooman Djaladat, MD, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-27
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2021-10-27
Study Completion Date2026-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • 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