Robot-Assisted Radical Prostatectomy With or Without Vesicopexy in Patients With Prostate Cancer
NCT ID: NCT04981834
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
196 participants
INTERVENTIONAL
2021-10-27
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm I (radical prostatectomy, vesicopexy)
Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Radical Prostatectomy
Undergo RARP
Vesicopexy
Undergo vesicopexy
Arm II (radical prostatectomy)
Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Radical Prostatectomy
Undergo RARP
Interventions
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Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Radical Prostatectomy
Undergo RARP
Vesicopexy
Undergo vesicopexy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 neuropathic bladder
* Any drug or alcohol addiction
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Hooman Djaladat, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2021-05989
Identifier Type: REGISTRY
Identifier Source: secondary_id
4P-21-1
Identifier Type: OTHER
Identifier Source: secondary_id
4P-21-1
Identifier Type: -
Identifier Source: org_study_id
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