Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:18 PM
Study NCT ID:
NCT04981834
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2021-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robot-Assisted Radical Prostatectomy With or Without Vesicopexy in Patients With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 196}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2021-07-27', 'studyFirstSubmitQcDate': '2021-07-27', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-month (+/- 3 weeks) urinary continence rate following RARP with or without vesicopexy', 'timeFrame': '3 months post-operative', 'description': 'Defined continence as 0-1 safety pad usage. Use the "pictorial pad usage questionnaire."'}], 'secondaryOutcomes': [{'measure': '3-month (+/- 3 weeks) quality of life following surgery', 'timeFrame': '3 months post-operative', 'description': 'Use the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ-PR25).'}, {'measure': '72-hour postop urinary continence following surgery', 'timeFrame': '72 hours post-operative', 'description': 'Defined continence as 0-1 safety pad usage. Assessed with the "pictorial pad usage questionnaire."'}, {'measure': '1-month (+/- 1 week) post-operative urinary continence following surgery', 'timeFrame': '1 month post-operative', 'description': 'Defined continence as 0-1 safety pad usage. Assessed with the "pictorial pad usage questionnaire."'}, {'measure': 'Sexual function at 3-month (+/- 3 weeks) following surgery', 'timeFrame': '3 months post-operative', 'description': 'Sexual Health Inventory for Men (SHIM) questionnaire is used for the evaluation of sexual function.'}, {'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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine the 3-month (+/- 3 weeks) urinary continence following RARP with or without vesicopexy.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the 3-month (+/- 3 weeks) quality of life following RARP with or without vesicopexy.\n\nII. To evaluate the 72-hour post-operative (postop) urinary continence following RARP with or without vesicopexy.\n\nIII. To evaluate the 1-month (+/- 1 week) postop urinary continence following RARP with or without vesicopexy.\n\nIV. To evaluate sexual function at 3-month (+/- 3 weeks) following RARP with or without vesicopexy.\n\nV. To evaluate the operative time in patients undergoing RARP with or without vesicopexy.\n\nVI. To evaluate intraoperative complications in patients undergoing RARP with or without vesicopexy.\n\nVII. To evaluate 90-day post-operative complications in patients undergoing RARP with or without vesicopexy.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.\n\nARM II: Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.\n\nAfter study completion, patients will be followed-up with at 24 hours, 1-month, and 3-months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men with age \\> 18 years\n* Prostate cancer patients undergoing RARP with anterior approach at University of Southern California (USC) urology\n* Ability to understand and the willingness to sign a written informed consent\n* Clinical stage \\< 4 and (M0) prostate cancer\n* Eastern Cooperative Oncology Group (ECOG) performance score 0-1\n* Pre-operative (op) urinary continence\n* Negative history of pelvic radiation and/or previous local therapy for prostate cancer (i.e., radiation or focal therapy)\n\nExclusion Criteria:\n\n* Any history of psychiatric, neurologic or cognitive disease\n* Any history of neuropathic bladder\n* Any drug or alcohol addiction'}, 'identificationModule': {'nctId': 'NCT04981834', 'briefTitle': 'Robot-Assisted Radical Prostatectomy With or Without Vesicopexy in Patients With Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'The Effect of Vesicopexy on Urinary Continence and Quality of Life Following Robotic-Assisted Radical Prostatectomy: A Phase III Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '4P-21-1'}, 'secondaryIdInfos': [{'id': 'NCI-2021-05989', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '4P-21-1', 'type': 'OTHER', 'domain': 'USC / Norris Comprehensive Cancer Center'}, {'id': 'P30CA014089', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014089', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (radical prostatectomy, vesicopexy)', 'description': 'Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.', 'interventionNames': ['Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Procedure: Radical Prostatectomy', 'Procedure: Vesicopexy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (radical prostatectomy)', 'description': 'Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.', 'interventionNames': ['Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Procedure: Radical Prostatectomy']}], 'interventions': [{'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (radical prostatectomy, vesicopexy)', 'Arm II (radical prostatectomy)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (radical prostatectomy, vesicopexy)', 'Arm II (radical prostatectomy)']}, {'name': 'Radical Prostatectomy', 'type': 'PROCEDURE', 'otherNames': ['Prostatovesiculectomy'], 'description': 'Undergo RARP', 'armGroupLabels': ['Arm I (radical prostatectomy, vesicopexy)', 'Arm II (radical prostatectomy)']}, {'name': 'Vesicopexy', 'type': 'PROCEDURE', 'otherNames': ['Cystopexy', 'Vesicofixation'], 'description': 'Undergo vesicopexy', 'armGroupLabels': ['Arm I (radical prostatectomy, vesicopexy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ileana Aldana', 'role': 'CONTACT', 'email': 'Ileana.Aldana@med.usc.edu', 'phone': '323-865-3700'}, {'name': 'Hooman Djaladat, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'USC / Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Ileana Aldana', 'role': 'CONTACT', 'email': 'Ileana.aldana@med.usc.edu', 'phone': '323-865-3700'}], 'overallOfficials': [{'name': 'Hooman Djaladat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}