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

University of Southern California

Status: Suspended

Conditions: Stage IIIC Prostate Cancer AJCC v8; Stage I Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8

Treatments: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Vesicopexy; Procedure: Radical Prostatectomy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04981834

NCI-2021-05989 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

4P-21-1 (Other Identifier)

Details and patient eligibility

About

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.

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 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.

Enrollment: 196 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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196 participants in 2 patient groups

Arm I (radical prostatectomy, vesicopexy)

Experimental group

Description:

Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.

Treatment:

Procedure: Radical Prostatectomy

Procedure: Vesicopexy

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Arm II (radical prostatectomy)

Active Comparator group

Description:

Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.

Treatment:

Procedure: Radical Prostatectomy

Other: Questionnaire Administration

Other: Quality-of-Life Assessment