Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-29 @ 12:15 PM
Study NCT ID:
NCT00596895
Status:
COMPLETED
Last Update Posted:
2011-09-20
First Post:
2008-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563250', 'term': 'Salivary Gland Adenoma, Pleomorphic'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007529', 'term': 'Isoflavones'}, {'id': 'D041942', 'term': 'Soy Milk'}], 'ancestors': [{'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'}, {'id': 'D041941', 'term': 'Milk Substitutes'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D045730', 'term': 'Soy Foods'}, {'id': 'D000067075', 'term': 'Vegetable Products'}, {'id': 'D014675', 'term': 'Vegetables'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-16', 'studyFirstSubmitDate': '2008-01-08', 'studyFirstSubmitQcDate': '2008-01-16', 'lastUpdatePostDateStruct': {'date': '2011-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the effect of soy protein/isoflavones serum PSA levels in patients previously treated with radical prostatectomy and external beam radiation therapy.', 'timeFrame': 'Baseline, 3, 6, 9 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Assess the effect of soy protein/isoflavones on serum testosterone, isoflavone metabolites, and cholesterol. Assess the effect of soy protein/isoflavones on quality of life of these patients.', 'timeFrame': 'Baseline, 3, 6, 9 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Isoflavone, PSA, prostate cancer, recurrent, quality of life'], 'conditions': ['Biochemical Recurrent Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '18471323', 'type': 'DERIVED', 'citation': 'Pendleton JM, Tan WW, Anai S, Chang M, Hou W, Shiverick KT, Rosser CJ. Phase II trial of isoflavone in prostate-specific antigen recurrent prostate cancer after previous local therapy. BMC Cancer. 2008 May 11;8:132. doi: 10.1186/1471-2407-8-132.'}]}, 'descriptionModule': {'briefSummary': 'Primary Outcome Measures:\n\nDecrease in rate of serum PSA rise\n\nSecondary Outcome Measures:\n\nAdherence to treatment regimens\n\nQuality of life as assessed by FACT-P at baseline and at 12 months of treatment\n\nModulation of serum testosterone,isoflavone metabolites, and cholesterol\n\nEstimated Enrollment: 27 Study Start Date: November 2003 Estimated Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)', 'detailedDescription': '* Pretreatment evaluation included a complete medical history, physical examination (including digital rectal examination), serum PSA, free/total testosterone, lipids, serum isoflavone levels (genistein, daidzein, and equol), and assessment of quality of life (Functional Assessment of Cancer Treatment-Prostate, FACT-P questionnaire).\n* Whole blood will be obtained prior to initiation of the study to assess for DNA polymorphism.\n* Follow-up serum PSA levels to assess efficacy were obtained at 3, 6, 9, and 12 months after initiation of treatment.\n* Medical history, physical examination, serum testosterone, lipids, isoflavone, and quality of life were assessed at 6 and 12 months after initiation of treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Raising serum PSA profile after previous definitive therapy (e.g., radical prostatectomy or external beam radiation therapy).\n* Life expectancy of at least one year and performance status of \\<2 of Zubrod scale.\n\nExclusion Criteria:\n\n* Metastatic or locally recurrent disease demonstrated on bone scan, computed tomography or transrectal ultrasound, or be clinically symptomatic at the time of enrollment\n* No androgen deprivation therapy (ADT) or chemotherapy within 12 months of entry into the study.\n* Known allergic reaction to milk or soy products were excluded.'}, 'identificationModule': {'nctId': 'NCT00596895', 'briefTitle': 'Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Phase II Trial of Isoflavone in Prostate-specific Antigen Recurrent Prostate Cancer After Previous Local Therapy.', 'orgStudyIdInfo': {'id': 'UFJ2003-113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Isoflavone treatment', 'interventionNames': ['Dietary Supplement: Isoflavone']}], 'interventions': [{'name': 'Isoflavone', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Soy Dream Enriched, Original or Vanilla, soy milk'], 'description': 'Ingested 47 mg of isoflavone in three 8 oz servings per day', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Shands', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Charles J. Rosser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}