Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-30 @ 9:11 PM
Study NCT ID:
NCT00928850
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2009-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modifications to Radical Prostatectomy: Feasibility Study
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-19', 'studyFirstSubmitDate': '2009-06-25', 'studyFirstSubmitQcDate': '2009-06-25', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To pilot a randomized trial of modifications to radical prostatectomy to determine:Proportion of patients accrued and Accrual rate', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Determine surgeon compliance with allocation', 'timeFrame': '1 year'}]}, 'conditionsModule': {'keywords': ['Prostate', 'Radical Prostatectomy', 'urethral irrigation', 'fascial suturing', '09-051'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '22364367', 'type': 'DERIVED', 'citation': 'Vickers AJ, Bennette C, Touijer K, Coleman J, Laudone V, Carver B, Eastham JA, Scardino PT. Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy. Trials. 2012 Feb 24;13:23. doi: 10.1186/1745-6215-13-23.'}], 'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This study aims to determine whether surgeons at Memorial Sloan-Kettering Cancer Center are able to randomize patients to test modifications of surgery to remove the prostate. Surgery to remove the prostate is known as a "radical prostatectomy". Surgeons know many things about the best way to do a radical prostatectomy. However, there is disagreement about some aspects of surgery. Two modifications of surgery to remove the prostate (radical prostatectomy) identified for this study include Irrigation, and Fascial Suturing.\n\nTwo aspects of the operation may vary, fascial suturing and urethral irrigation. For each aspect, surgeons will use their clinical judgment as to the best interests of the patient. In other words, if there are clear reasons to use or avoid a fascial suturing approach, the surgeon will act accordingly; similarly, if there is a clear reason to irrigate or avoid irrigating the urethra, the surgeon can make the appropriate clinical decision. If the surgeon is unsure as to which approach to take, then the randomization scheme will be followed.\n\nAll of the surgeons who are taking part in this study have used these techniques at different times. However, they are unsure as to the best approach. Sometimes, they use different treatments with different patients.\n\nIrrigation. Cancer cells can spill during surgery and this can cause cancer to return ("recur"). Some surgeons believe that "irrigating" could help stop spilling of cancer cells. "Irrigating" means washing the surgical area with sterile water and sucking the water back up through a tube. As a result, surgeons vary as to how they irrigate. In this study, we will examine irrigation of the urethra. This is the part of the body that carries urine from the bladder to the penis.\n\nFascial suturing. Surgeons believe that what happens to the urethra can affect the risk of incontinence. This is when a patient cannot control urine, and drips or leaks urine. One idea is that additional stitches ("sutures") to the connective tissue ("fascia") could be helpful, but this is not known for sure.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKCC.\n\nExclusion Criteria:\n\n* Prior treatment for prostate cancer: radiation, hormonal therapy, chemotherapy or focal therapy.'}, 'identificationModule': {'nctId': 'NCT00928850', 'briefTitle': 'Modifications to Radical Prostatectomy: Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'A Randomized Trial of Modifications to Radical Prostatectomy: Feasibility Study', 'orgStudyIdInfo': {'id': '09-051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'urethral irrigation but no fascial suturing, QOL forms', 'description': "The anterior two-thirds of the urethra is divided exposing a Foley catheter that was placed at the beginning of the procedure. Irrigation of the urethra may prevent spread of prostate cancer cells to tissue that is not removed during surgery. The urethra is irrigated with 60 cc of sterile water as it is withdrawn from the patient to 'wash' the urethra.", 'interventionNames': ['Procedure: radical prostatectomy with urethral irrigation but no fascial suturing, QOL forms']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fascial suturing but no urethral irrigation, QOL forms', 'description': 'For patients undergoing fascial suturing only, after the initial placement of the suture through the urethra a second bite is taken deeply into the fascia of the lateral pelvic fascia.', 'interventionNames': ['Procedure: radical prostatectomy with fascial suturing but no urethral irrigation, QOL forms']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'both urethral irrigation and fascial suturing, QOL forms', 'interventionNames': ['Procedure: radical prostatectomy with both urethral irrigation and fascial suturing, QOL forms']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'neither urethral irrigation nor fascial suturing, QOL forms', 'interventionNames': ['Procedure: radical prostatectomy with neither urethral irrigation nor fascial suturing, QOL forms']}], 'interventions': [{'name': 'radical prostatectomy with urethral irrigation but no fascial suturing, QOL forms', 'type': 'PROCEDURE', 'description': 'Cancer cells can spill during surgery and this can cause cancer to return ("recur"). Some surgeons believe that "irrigating" could help stop spilling of cancer cells. "Irrigating" means washing the surgical area with sterile water and sucking the water back up through a tube. As a result, surgeons vary as to how they irrigate. In this study, we will examine irrigation of the urethra. This is the part of the body that carries urine from the bladder to the penis. Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery', 'armGroupLabels': ['urethral irrigation but no fascial suturing, QOL forms']}, {'name': 'radical prostatectomy with fascial suturing but no urethral irrigation, QOL forms', 'type': 'PROCEDURE', 'description': 'Surgeons believe that what happens to the urethra can affect the risk of incontinence. This is when a patient cannot control urine, and drips or leaks urine. One idea is that additional stitches ("sutures") to the connective tissue ("fascia") could be helpful, but this is not known for sure. Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery', 'armGroupLabels': ['fascial suturing but no urethral irrigation, QOL forms']}, {'name': 'radical prostatectomy with both urethral irrigation and fascial suturing, QOL forms', 'type': 'PROCEDURE', 'description': 'Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery', 'armGroupLabels': ['both urethral irrigation and fascial suturing, QOL forms']}, {'name': 'radical prostatectomy with neither urethral irrigation nor fascial suturing, QOL forms', 'type': 'PROCEDURE', 'description': 'Quality of life are assessed for clinical evaluation approximately 3, 6, 9, 12, 18, 24, 36 and 48 months after surgery', 'armGroupLabels': ['neither urethral irrigation nor fascial suturing, QOL forms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Andrew Vickers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}