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

Sponsor
University of Southern California (Other)
Overall Status
Recruiting
CT.gov ID
NCT04981834
Collaborator
National Cancer Institute (NCI) (NIH)
164
1
2
36
4.6

Study Details

Study Description

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:
  1. To determine the 3-month (+/- 3 weeks) urinary continence following RARP with or without vesicopexy.
SECONDARY OBJECTIVES:
  1. To evaluate the 3-month (+/- 3 weeks) quality of life following RARP with or without vesicopexy.

  2. To evaluate the 24-hour post-operative (postop) urinary continence following RARP with or without vesicopexy.

  3. To evaluate the 1-month (+/- 1 week) postop urinary continence following RARP with or without vesicopexy.

  4. To evaluate sexual function at 3-month (+/- 3 weeks) following RARP with or without vesicopexy.

  5. To evaluate the operative time in patients undergoing RARP with or without vesicopexy.

  6. To evaluate intraoperative complications in patients undergoing RARP with or without vesicopexy.

  7. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
164 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Effect of Vesicopexy on Urinary Continence and Quality of Life Following Robotic-Assisted Radical Prostatectomy: A Phase III Randomized Clinical Trial
Actual Study Start Date :
Oct 27, 2021
Anticipated Primary Completion Date :
Oct 27, 2023
Anticipated Study Completion Date :
Oct 27, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    2. 24-hour postop urinary continence following surgery [24 hours post-operative]

      Defined continence as 0-1 safety pad usage. Assessed with the "pictorial pad usage questionnaire."

    3. 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."

    4. 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.

    5. Operative time [Duration of operation]

    6. Intra-operative complications [Duration of operation]

    7. 90-day post-operative complications [90 days post-operative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033

    Sponsors and Collaborators

    • University of Southern California
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Hooman Djaladat, MD, University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Southern California
    ClinicalTrials.gov Identifier:
    NCT04981834
    Other Study ID Numbers:
    • 4P-21-1
    • NCI-2021-05989
    • 4P-21-1
    • P30CA014089
    First Posted:
    Jul 29, 2021
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 10, 2022