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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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

Intervention / Treatment
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* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Procedure: Radical Prostatectomy
* Procedure: Vesicopexy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (radical prostatectomy, vesicopexy)<br>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<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Radical Prostatectomy<br>* Undergo RARP<br>* Other names: Prostatovesiculectomy;Procedure: Vesicopexy<br>* Undergo vesicopexy<br>* Other names: Vesicofixation;|
| Active Comparator: Arm II (radical prostatectomy)<br>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<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Radical Prostatectomy<br>* Undergo RARP<br>* Other names: Prostatovesiculectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-month (+/- 3 weeks) quality of life following surgery | Use the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ-PR25). | 3 months post-operative | 
| 72-hour postop urinary continence following surgery | Defined continence as 0-1 safety pad usage. Assessed with the pictorial pad usage questionnaire. | 72 hours post-operative | 
| 1-month (+/- 1 week) post-operative urinary continence following surgery | Defined continence as 0-1 safety pad usage. Assessed with the pictorial pad usage questionnaire. | 1 month post-operative | 
| Sexual function at 3-month (+/- 3 weeks) following surgery | Sexual Health Inventory for Men (SHIM) questionnaire is used for the evaluation of sexual function. | 3 months post-operative | 
| Operative time |  | Duration of operation | 
| Intra-operative complications |  | Duration of operation | 
| 90-day post-operative complications |  | 90 days post-operative |