Clinical trial NCT04981834: Robot-Assisted Radical Prostatectomy With or Without Vesicopexy in Patients With Prostate Cancer
Official title: The Effect of Vesicopexy on Urinary Continence and Quality of Life Following Robotic-Assisted Radical Prostatectomy: A Phase III Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-07-29
Enrollment: 196
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: 3-month (+/- 3 weeks) urinary continence rate following RARP with or without vesicopexy
timeFrame: 3 months post-operative
Secondary outcomes:
measure: 3-month (+/- 3 weeks) quality of life following surgery
timeFrame: 3 months post-operative
measure: 72-hour postop urinary continence following surgery
timeFrame: 72 hours post-operative
measure: 1-month (+/- 1 week) post-operative urinary continence following surgery
timeFrame: 1 month post-operative
measure: Sexual function at 3-month (+/- 3 weeks) following surgery
timeFrame: 3 months post-operative
measure: Operative time
timeFrame: Duration of operation
measure: Intra-operative complications
timeFrame: Duration of operation
measure: 90-day post-operative complications
timeFrame: 90 days post-operative
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Hooman Djaladat, MD
role: PRINCIPAL_INVESTIGATOR
References: