Prostate Cancer Clinical Trial

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

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.

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Full 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 24-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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Prostate Cancer

Estimated Enrollment:

164

Study ID:

NCT04981834

Recruitment Status:

Recruiting

Sponsor:

University of Southern California

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There is 1 Location for this study

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USC / Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States More Info
Ileana Aldana
Contact
323-865-3700
[email protected]
Hooman Djaladat, MD
Principal Investigator

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

164

Study ID:

NCT04981834

Recruitment Status:

Recruiting

Sponsor:


University of Southern California

How clear is this clinincal trial information?

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