Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-25 @ 2:19 PM
Study NCT ID:
NCT00058266
Status:
TERMINATED
Last Update Posted:
2012-07-19
First Post:
2003-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019833', 'term': 'Genistein'}], 'ancestors': [{'id': 'D007529', 'term': 'Isoflavones'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'whyStopped': 'Data Monitoring Committee cited poor accrual.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'dispFirstSubmitDate': '2011-05-19', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-10', 'studyFirstSubmitDate': '2003-04-07', 'dispFirstSubmitQcDate': '2011-05-19', 'studyFirstSubmitQcDate': '2003-04-08', 'dispFirstPostDateStruct': {'date': '2011-05-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity', 'timeFrame': 'At surgery & monthly thereafter during treatment (3 mos)'}, {'measure': 'Decrease in prostate-specific antigen-positive cells', 'timeFrame': 'At time of surgery'}, {'measure': 'Alteration in cell morphology', 'timeFrame': 'At time of surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage I prostate cancer', 'stage II prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Genistein may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.\n\nPURPOSE: Phase II trial to study the effectiveness of genistein in treating patients with localized prostate cancer who are planning to undergo radical prostatectomy.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the toxicity of genistein in patients with localized prostate cancer treated with radical prostatectomy.\n* Determine the decrease, if any, of prostate-specific antigen-positive cells in the operative field of patients treated with this drug.\n* Determine the quality of life of patients treated with this drug.\n\nOUTLINE: Patients receive 1 of 2 treatment regimens.\n\n* Group A: Patients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy).\n* Group B: Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.\n\nQuality of life is assessed at baseline and at 1 and 3 months after surgery.\n\nPatients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 88 patients (44 patients per treatment group) will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of localized prostate cancer\n\n * Diagnosed within the past 6 months\n * T1 or T2 disease\n * Gleason score 5-8\n * Prostate-specific antigen no greater than 20 ng/mL\n* Radical prostatectomy planned\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* More than 2 years\n\nHematopoietic\n\n* Hemoglobin greater than 9.0 g/dL\n* Platelet count greater than 100,000/mm\\^3\n* Absolute neutrophil count greater than 1,000/mm\\^3\n\nHepatic\n\n* SGPT and SGOT less than 3 times normal\n* Bilirubin less than 3 mg/dL (less than 1.5 times normal) (patients with an elevated bilirubin due to a familial defect in bilirubin metabolism will be considered on an individual basis)\n\nRenal\n\n* Creatinine less than 2.0 mg/dL\n\nCardiovascular\n\n* No venous thrombosis within the past year\n\nOther\n\n* Patients must use effective barrier contraception\n* No other medical condition that would preclude study therapy\n* No known soy intolerance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* No concurrent hormonal therapy for prostate cancer\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* See Disease Characteristics\n\nOther\n\n* No concurrent soy supplements\n* No concurrent foods high in genistein\n* No concurrent active therapy for neoplastic disorders'}, 'identificationModule': {'nctId': 'NCT00058266', 'briefTitle': 'Genistein in Treating Patients With Localized Prostate Cancer Who Are Planning to Undergo Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'A Phase II Study Of Genistein In Patients With Localized Prostate Cancer (Molecular Correlates of Soy In Humans)', 'orgStudyIdInfo': {'id': 'NU 00U7'}, 'secondaryIdInfos': [{'id': 'NU-00U7'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Patients receive oral genistein once daily for 1-2 months, undergo radical prostatectomy, and then continue oral genistein once daily for 1-2 months afterward (for a total of 3 months of therapy).', 'interventionNames': ['Dietary Supplement: genistein', 'Procedure: conventional surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Patients undergo radical prostatectomy. Beginning 1 month after surgery, patients receive genistein as in arm I for 3 months.', 'interventionNames': ['Dietary Supplement: genistein', 'Procedure: conventional surgery']}], 'interventions': [{'name': 'genistein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Given orally', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'conventional surgery', 'type': 'PROCEDURE', 'description': 'Patients undergo surgery', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611-3013', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center at Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Lakeside Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201-1781', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Evanston Northwestern Healthcare - Evanston Hospital', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '60426', 'city': 'Harvey', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ingalls Cancer Care Center at Ingalls Memorial Hospital', 'geoPoint': {'lat': 41.61003, 'lon': -87.64671}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington School of Medicine', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Raymond C. Bergan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Robert H. Lurie Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}