Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT00584532
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2007-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C473311', 'term': 'genistein combined polysaccharide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2007-12-22', 'studyFirstSubmitQcDate': '2007-12-22', 'lastUpdatePostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in PSA levels in men on GCP', 'timeFrame': '6 Months'}], 'secondaryOutcomes': [{'measure': 'Increased PSA Doubling Time (PSADT)in men on GCP.', 'timeFrame': '6 Months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Localized', 'Prostate', 'Cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Genistein Combined Polysaccharide (GCP) may play a role as a secondary chemopreventive agent in the treatment of localized prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be male and have a pathological diagnosis of prostate cancer\n* Pathological diagnosis of prostate cancer must be confirmed and on file with CRA prior to study entry.\n* No treatment (surgery, radiation, or hormones) prior to study entry.\n* PSA between 2.0 and 10.0 ng/ml.\n* If PSA is \\>10.0, patient must have been on Active Surveillance for 12 months prior to study initiation.\n* No known allergy to soy or soy products.\n* The patient is not currently taking more than 2 grams of genistein a day in nutritional or diet enhancing supplements (OTC supplements).\n* Participant has not been on any previous GCP clinical trial.\n* Normal Chemistry values prior to study entry.\n\nExclusion Criteria:\n\n* No pathological documentation of prostate cancer.\n* Prior treatment for prostate cancer.\n* PSA \\>10.0 ng/ml but not on Active Surveillance for 12 months.\n* Allergy to soy or soy products.\n* Abnormal chemistry values.'}, 'identificationModule': {'nctId': 'NCT00584532', 'acronym': 'GCP', 'briefTitle': 'Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance.', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Effects of a Genistein Concentrated Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.', 'orgStudyIdInfo': {'id': '281609'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'description': 'A=Placebo ARM of Study', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'B=GCP Capsules. Ten 500 mg capsules per day for a total of 5 grams a day.', 'interventionNames': ['Drug: GCP - Genistein Combined Polysaccharide']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo capsules (contain cellulose only)'], 'description': '10 Placebo Capsules taken orally every day.', 'armGroupLabels': ['A']}, {'name': 'GCP - Genistein Combined Polysaccharide', 'type': 'DRUG', 'description': 'Ten 500 mg capsules given orally per day. Total of 5 grams per day per patient.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robert Hackman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis - Dept. of Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Robert Hackman, PhD', 'oldOrganization': 'University of California, Davis - Department of Nutrition'}}}}