Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage I Prostate Cancer AJCC v8
Conditions
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.
Interventions
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
PROCEDURERadical Prostatectomy
Undergo RARP
PROCEDUREVesicopexy
Undergo vesicopexy
Sponsors
University of Southern California
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 72-hour postop urinary continence following surgery | 72 hours post-operative | Defined continence as 0-1 safety pad usage. Assessed with the "pictorial pad usage questionnaire." |
| 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." |
| 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. |
| Operative time | Duration of operation | — |
| Intra-operative complications | Duration of operation | — |
| 90-day post-operative complications | 90 days post-operative | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHooman Djaladat, MD
University of Southern California
Outcome results
None listed