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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-05989 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 4P-21-1 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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Accrual goal reached and suspended for analysis purposes.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (radical prostatectomy, vesicopexy) | Experimental | Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion. |
|
| Arm II (radical prostatectomy) | Active Comparator | Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hooman Djaladat, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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| Questionnaire Administration | Other | Ancillary studies |
|
| Radical Prostatectomy | Procedure | Undergo RARP |
|
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| Vesicopexy | Procedure | Undergo vesicopexy |
|
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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 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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