Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT00607932
Status:
COMPLETED
Last Update Posted:
2016-04-27
First Post:
2008-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brassica Vegetables or Indole-3-Carbinol in Treating Patients With PSA Recurrence After Surgery for Prostate Cancer
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': 'C016517', 'term': 'indole-3-carbinol'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-26', 'studyFirstSubmitDate': '2008-02-01', 'studyFirstSubmitQcDate': '2008-02-02', 'lastUpdatePostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Brassica vegetable intake and indole-3-carbinol supplementation', 'timeFrame': 'will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention'}, {'measure': 'Adverse events', 'timeFrame': 'will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention'}, {'measure': 'Effects of intervention on prostate-specific antigen', 'timeFrame': 'Not noted'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Eating a diet high in vegetables may lower the risk of some types of cancer. Brassica vegetables (such as cabbages, kale, broccoli, Brussels sprouts, and cauliflower) and indole-3-carbinol (a substance found in cruciferous vegetables) may help lower the risk of prostate cancer recurrence.\n\nPURPOSE: This randomized clinical trial is studying the side effects and how well Brassica vegetables work compared with indole-3-carbinol in treating patients with PSA recurrence after surgery for prostate cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the feasibility of Brassica vegetable intake and indole-3-carbinol supplement use in patients with prostate cancer with prostate-specific antigen (PSA) recurrence after prostatectomy.\n* Identify adverse events in these patients.\n* Quantify the effects of each intervention on PSA in these patients.\n\nOUTLINE: Patients are stratified by pretreatment prostat-specific antigen (PSA) growth rate (low \\[0.00-0.15\\] vs medium \\[0.16-0.30\\] vs high \\[\\> 0.30\\]). They are randomized to 1 of 3 treatment arms, and randomization status to arms II and III is double-blinded.\n\n* Arm I (Brassica vegetables): Patients consume Brassica vegetables at least 2 servings (½ cup/serving) daily for 6 months. Patients meet one-on-one with the study dietician, and are instructed on the potential health benefits of Brassica vegetables and purchase and preparation of the vegetables. Patients undergo telephone counseling periodically in months 1-5, to monitor their progress and identify barriers to adherence and to develop solutions to overcome these barriers.\n* Arm II (Placebo): Patients receive oral placebo once daily for 6 months.\n* Arm III (Indole-3-carbinol supplement): Patients receive oral indole-3-carbinol supplement (capsules) once daily for 6 months.\n\nBlood and urine samples (for urinary isothiocyanate levels) are collected at baseline and at 2, 4, and 6 months. Patients complete questionnaires assessing demographics, family cancer history, and health history and measuring changes in medications, lifestyle, adverse events, and health. Medical records are reviewed for prostate cancer-related information, surgical dates, dose and type of radiation, and PSA history.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of prostate cancer with PSA recurrence after prostatectomy\n\n * PSA recurrence is defined as two consecutively rising PSA tests ≥ 8 weeks since the post-surgical nadir, with a minimal interval of 2 weeks between tests and at least 1 PSA test \\> 0.4 ng/mL\n\nExclusion Criteria:\n\n* Life expectancy ≥ 9 months\n* No predictors of poor adherence (e.g., erratic life-style, mental incompetence)\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No other concurrent Brassica vegetable consumption \\> 1 serving/day\n* No other concurrent indole-3-carbinol supplements\n* No endocrine or radiation treatment within past 4 weeks\n* No other scheduled treatment during study intervention\n* Concurrent prescription medications during the trial allowed\n\n * At least 2 weeks since prior and no concurrent vitamin or herbal supplement use\n\n * Patients refusing to stop non-study supplements will be asked to maintain constant use'}, 'identificationModule': {'nctId': 'NCT00607932', 'briefTitle': 'Brassica Vegetables or Indole-3-Carbinol in Treating Patients With PSA Recurrence After Surgery for Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Effects of Bassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrence', 'orgStudyIdInfo': {'id': 'CDR0000581410'}, 'secondaryIdInfos': [{'id': 'VU-VICC-URO-0369'}, {'id': 'VU-VICC-041001'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brassica Vegetables Diet Intervention', 'interventionNames': ['Behavioral: behavioral dietary intervention', 'Dietary Supplement: Brassica vegetable', 'Drug: indole-3-carbinol', 'Other: counseling intervention', 'Other: medical chart review', 'Other: questionnaire administration', 'Procedure: adjuvant therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Pill', 'interventionNames': ['Drug: indole-3-carbinol', 'Other: counseling intervention', 'Other: medical chart review', 'Other: questionnaire administration', 'Procedure: adjuvant therapy']}], 'interventions': [{'name': 'behavioral dietary intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Brassica Vegetables Diet Intervention']}, {'name': 'Brassica vegetable', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Brassica Vegetables Diet Intervention']}, {'name': 'indole-3-carbinol', 'type': 'DRUG', 'otherNames': ['I3C'], 'description': 'follow up at 2,4,6 months post baseline.', 'armGroupLabels': ['Brassica Vegetables Diet Intervention', 'Pill']}, {'name': 'counseling intervention', 'type': 'OTHER', 'description': '2, 4, 6 months post baseline', 'armGroupLabels': ['Brassica Vegetables Diet Intervention', 'Pill']}, {'name': 'medical chart review', 'type': 'OTHER', 'description': '2,4,6 months post baseline', 'armGroupLabels': ['Brassica Vegetables Diet Intervention', 'Pill']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'armGroupLabels': ['Brassica Vegetables Diet Intervention', 'Pill']}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE', 'armGroupLabels': ['Brassica Vegetables Diet Intervention', 'Pill']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jay H. Fowke, PhD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jay Fowke', 'investigatorAffiliation': 'Vanderbilt University'}}}}