Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-05 @ 6:17 PM
Study NCT ID:
NCT00579332
Status:
COMPLETED
Last Update Posted:
2016-04-27
First Post:
2007-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Brassica or Indole-3-carbinol on Prostatectomy Patients With PSA Recurrence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-26', 'studyFirstSubmitDate': '2007-12-18', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in blood PSA levels', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'monitor for health events', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PSA', 'biochemical failure'], 'conditions': ['Biochemical Failure']}, 'descriptionModule': {'briefSummary': 'Pilot and feasibility diet and phyto-agent intervention among healthy men at risk for prostate cancer progression.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men with PSA recurrence following prostatectomy\n\nExclusion Criteria:\n\n* Not using exogenous hormones'}, 'identificationModule': {'nctId': 'NCT00579332', 'briefTitle': 'Effects of Brassica or Indole-3-carbinol on Prostatectomy Patients With PSA Recurrence', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Effects of Brassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrenc', 'orgStudyIdInfo': {'id': '041001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'one a day placebo', 'interventionNames': ['Dietary Supplement: brassica intervention']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Brassica intake', 'interventionNames': ['Dietary Supplement: brassica intervention']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'indole-3-carbinol supplement', 'interventionNames': ['Dietary Supplement: brassica intervention']}], 'interventions': [{'name': 'brassica intervention', 'type': 'DIETARY_SUPPLEMENT', 'description': 'diet and phyto-chemical intervention', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23233', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt_University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Jay H Fowke, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Institute of Cancer Prevention', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jay Fowke', 'investigatorAffiliation': 'Vanderbilt University'}}}}