Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-27 @ 8:56 PM
Study NCT ID:
NCT00887432
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2009-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D057832', 'term': 'Watchful Waiting'}, {'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kris.Attwood@roswellpark.org', 'phone': '716-845-1300', 'title': 'Kris Attwood', 'organization': 'Roswell Park Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Within 30 days of treatment completion (up to 22 months from start of study).', 'eventGroups': [{'id': 'EG000', 'title': 'Cholecalciferol', 'description': 'Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity.\n\nCholecalciferol: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPatient Observation\n\nPlacebo Administration: Given PO\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 2, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity.\n\nCholecalciferol: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPatient Observation\n\nPlacebo Administration: Given PO\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 2, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PSA Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholecalciferol', 'description': 'Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity.\n\nCholecalciferol: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPatient Observation\n\nPlacebo Administration: Given PO\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity.\n\nCholecalciferol: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPatient Observation\n\nPlacebo Administration: Given PO\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '1.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.431', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.84', 'pValueComment': 'Significance level of 0.05.', 'groupDescription': 'Evaluated the change in PSA under the vitamin D and placebo conditions using the combined data (n=87).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Paired t-test, df=86'}], 'paramType': 'MEAN', 'timeFrame': '9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment', 'description': 'Difference in the mean change in PSA on vitamin D (9 month period: pre-Vitamin D to 9 months after start of vitamin D) versus on placebo (9 month period: pre-Placebo to 9 months after starting placebo).\n\nCompared using a paired t-test.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed both periods.'}, {'type': 'SECONDARY', 'title': 'Slope of PSA Concentration Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholecalciferol', 'description': 'Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity.\n\nCholecalciferol: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPatient Observation\n\nPlacebo Administration: Given PO\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity.\n\nCholecalciferol: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPatient Observation\n\nPlacebo Administration: Given PO\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '0.000434', 'spread': '0.000089', 'groupId': 'OG000'}, {'value': '0.000245', 'spread': '0.000090', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.112', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00019', 'ciLowerLimit': '-0.00042', 'ciUpperLimit': '0.000045', 'pValueComment': 'Significance level of 0.05.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Comparing the mean PSA slopes between conditions (on vitamin D versus on placebo).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment -Up to 30 days after completion of study treatment', 'description': 'The PSA levels were modeled as a function of treatment, time, their interaction, sequence, and a random subject effect using a linear mixed model. From this model, the subject specific PSA slope was obtained for each subject under each condition (vitamin D versus placebo). The PSA slopes were then compared between treatment conditions using linear mixed model to account for treatment arm and repeated measures.', 'unitOfMeasure': '(ng/mL) / day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Including evaluable patients, those patients with data available under both the vitamin D and placebo conditions.'}, {'type': 'SECONDARY', 'title': 'Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholecalciferol', 'description': 'Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity.\n\nCholecalciferol: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPatient Observation\n\nPlacebo Administration: Given PO\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity.\n\nCholecalciferol: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPatient Observation\n\nPlacebo Administration: Given PO\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}], 'classes': [{'categories': [{'title': 'No AE', 'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 3', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Grade 5', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 days after completion of study treatment (up to 22 months from start of study).', 'description': 'Summarizing the maximum observed treatment related adverse event. Summarize by arm and grade using frequencies and relative frequencies..', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients receiving any treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cholecalciferol to Placebo', 'description': 'Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to placebo PO QD for 9 months.\n\nCholecalciferol: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPatient Observation\n\nPlacebo Administration: Given PO\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'FG001', 'title': 'Placebo to Cholecalciferol', 'description': 'Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Cholecalciferol PO QD for 9 months.\n\nCholecalciferol: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPatient Observation\n\nPlacebo Administration: Given PO\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Start Excluded Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not complete treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No reason provided', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Cholecalciferol and Placebo)', 'description': 'Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to placebo PO QD for 9 months.\n\nCholecalciferol: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPatient Observation\n\nPlacebo Administration: Given PO\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'BG001', 'title': 'Arm II (Placebo and Cholecalciferol)', 'description': 'Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to cholecalciferol PO QD for 9 months.\n\nCholecalciferol: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPatient Observation\n\nPlacebo Administration: Given PO\n\nQuality-of-Life Assessment: Ancillary studies\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.5', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '64.9', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '64.3', 'spread': '6.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Serum 25(OH)D3', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25.1', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '30.4', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '27.9', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline vitamin D measured in serum blood samples.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Lab values were not recorded for all patients.'}, {'title': 'Prostate Specific Antigen (PSA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '4.8', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '5.0', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The PSA at enrollment was not available for all subejcts.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-26', 'size': 378291, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-04T13:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-06', 'studyFirstSubmitDate': '2009-04-23', 'resultsFirstSubmitDate': '2021-05-25', 'studyFirstSubmitQcDate': '2009-04-23', 'lastUpdatePostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-16', 'studyFirstPostDateStruct': {'date': '2009-04-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PSA Response', 'timeFrame': '9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment', 'description': 'Difference in the mean change in PSA on vitamin D (9 month period: pre-Vitamin D to 9 months after start of vitamin D) versus on placebo (9 month period: pre-Placebo to 9 months after starting placebo).\n\nCompared using a paired t-test.'}], 'secondaryOutcomes': [{'measure': 'Slope of PSA Concentration Over Time', 'timeFrame': '9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment -Up to 30 days after completion of study treatment', 'description': 'The PSA levels were modeled as a function of treatment, time, their interaction, sequence, and a random subject effect using a linear mixed model. From this model, the subject specific PSA slope was obtained for each subject under each condition (vitamin D versus placebo). The PSA slopes were then compared between treatment conditions using linear mixed model to account for treatment arm and repeated measures.'}, {'measure': 'Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0', 'timeFrame': 'Up to 30 days after completion of study treatment (up to 22 months from start of study).', 'description': 'Summarizing the maximum observed treatment related adverse event. Summarize by arm and grade using frequencies and relative frequencies..'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prostate Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial studies how well cholecalciferol supplement works in treating patients with localized prostate cancer undergoing observation. Cholecalciferol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the prostate-specific antigen (PSA) response with oral high dose vitamin D3 supplementation (cholecalciferol) in patients with localized, histologically proven adenocarcinoma of the prostate who have not received any treatment for prostate cancer ever and have chosen expectant management.\n\nSECONDARY OBJECTIVES:\n\nI. To examine the pattern of response of PSA dynamics as well as the absolute change in PSA following vitamin D3 supplementation.\n\nII. Assess the toxicity of vitamin D3 supplementation in men with prostate cancer.\n\nTERTIARY OBJECTIVES:\n\nI. Track occurrence of infections, deep venous thrombosis, vascular events and falls in the study population.\n\nII. To evaluate relationship between cytochrome P450 family 24 (CYP24), 27B1, single-nucleotide polymorphism (SNPs) and serum 25(hydroxy \\[OH\\]) vitamin D response to oral D3 supplementation.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients receive cholecalciferol orally (PO) once daily (QD) for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm II.\n\nARM II: Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm I.\n\nAfter completion of study treatment, patients are followed up for 30 days.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient with clinically localized, histologically proven adenocarcinoma of prostate who has not received any treatment for prostate cancer ever and has chosen active surveillance; treatment for prostate cancer is defined as prostatectomy, androgen deprivation, brachytherapy or a full course of external beam irradiation\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Willingness to comply with study guidelines\n* Willingness and ability to consent\n* 25(OH) D3 level less than 40 ng/ml within 3 months of initiation of study; most recent 25 hydroxy D level within last 3 month would be used\n\nExclusion Criteria:\n\n* History of malabsorption syndrome e.g., pancreatic insufficiency, celiac disease, tropical sprue\n* Creatinine \\> 2.0 mg/dL\n* Corrected serum calcium level of \\> 10.5 mg/dL (serum corrected calcium = serum calcium + 0.8\\[4-serum albumin\\])\n* Most recent PSA value more than 18 months ago\n* Prior or current therapy for prostate cancer\n* Documented history of nephrolithiasis within the past 5 years\n* Patients receiving finasteride (Proscar) or dutasteride (Avodart) or men who have received either agent within 90 days of entry are ineligible\n* Patients cannot take any additional vitamin D supplementation during study treatment; patients taking \\> 2000 IU per day prior to treatment will be ineligible'}, 'identificationModule': {'nctId': 'NCT00887432', 'briefTitle': 'Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'Randomized Placebo-Controlled, Double-Blind Study of Cholecalciferol Replacement in Patients on Expectant Management for Localized Prostate Cancer', 'orgStudyIdInfo': {'id': 'I 128308'}, 'secondaryIdInfos': [{'id': 'NCI-2009-01530', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'I 128308', 'type': 'OTHER', 'domain': 'Roswell Park Cancer Institute'}, {'id': 'P30CA016056', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016056', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (cholecalciferol and placebo)', 'description': 'Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm II.', 'interventionNames': ['Dietary Supplement: Cholecalciferol', 'Other: Laboratory Biomarker Analysis', 'Other: Patient Observation', 'Drug: Placebo Administration', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (placebo and cholecalciferol)', 'description': 'Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm I.', 'interventionNames': ['Dietary Supplement: Cholecalciferol', 'Other: Laboratory Biomarker Analysis', 'Other: Patient Observation', 'Drug: Placebo Administration', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Cholecalciferol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['9,10-Secocholesta-5,7,10(19)-trien-3-ol', 'Calciol', 'Delsterol', 'Vitamin D3'], 'description': 'Given PO', 'armGroupLabels': ['Arm I (cholecalciferol and placebo)', 'Arm II (placebo and cholecalciferol)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (cholecalciferol and placebo)', 'Arm II (placebo and cholecalciferol)']}, {'name': 'Patient Observation', 'type': 'OTHER', 'otherNames': ['Active Surveillance', 'deferred therapy', 'expectant management', 'Observation', 'Watchful Waiting'], 'armGroupLabels': ['Arm I (cholecalciferol and placebo)', 'Arm II (placebo and cholecalciferol)']}, {'name': 'Placebo Administration', 'type': 'DRUG', 'description': 'Given PO', 'armGroupLabels': ['Arm I (cholecalciferol and placebo)', 'Arm II (placebo and cholecalciferol)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (cholecalciferol and placebo)', 'Arm II (placebo and cholecalciferol)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (cholecalciferol and placebo)', 'Arm II (placebo and cholecalciferol)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'James Mohler', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}