Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT02758132
Status:
TERMINATED
Last Update Posted:
2019-11-08
First Post:
2016-04-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000069448', 'term': 'Denosumab'}, {'id': 'C540278', 'term': 'enzalutamide'}, {'id': 'C089740', 'term': 'abiraterone'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'smercado@cc.hawaii.edu', 'phone': '8084404561', 'title': 'Stacy Mercado', 'organization': 'University of Hawaii Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Trial was terminated early due to low accrual of one subject. Data analysis not conducted due to the one enrolled subject not receiving all the treatment.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were captured over 6 months', 'description': 'adverse event collection performed by standard collection practices, medical chart review, disclosure from subject', 'eventGroups': [{'id': 'EG000', 'title': 'Alliance A031201', 'description': 'Denosumab plus enzalutamide, abiraterone and prednisone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily\n\nAbiraterone: 1000 mg abiraterone by mouth daily\n\nPrednisone: 5 mg prednisone by mouth twice daily', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Denosumab plus enzalutamide alone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'intracranial hemorrhage', 'notes': 'subject was admitted to the hospital on 9/3/2016. Subject had a significant history of CVA (stroke) with atrial fibrillation. Patient elected hospice and care expired on 9/8/2016. The event was a grade 5 and deemed unrelated to study treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 4.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measure Change in Serum-based Metabolites Associated With Bone Deposition, Growth and Turnover in Patients Who Have CRPC With Clinical Evidence of Metastatic Disease to the Bone, All Using Gas Chromatography-time-of-flight Mass Spectrometry (GC-TOFMS).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alliance A031201', 'description': 'Denosumab plus enzalutamide, abiraterone and prednisone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily\n\nAbiraterone: 1000 mg abiraterone by mouth daily\n\nPrednisone: 5 mg prednisone by mouth twice daily'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Denosumab plus enzalutamide alone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily'}], 'timeFrame': 'Prior to Registration, Registration, Day 1 of cycle 4 and 13', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient expired before completing study'}, {'type': 'SECONDARY', 'title': 'Measure Time (Months) to Skeletal Related Event (SRE) of Patients on Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alliance A031201', 'description': 'Denosumab plus enzalutamide, abiraterone and prednisone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily\n\nAbiraterone: 1000 mg abiraterone by mouth daily\n\nPrednisone: 5 mg prednisone by mouth twice daily'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Denosumab plus enzalutamide alone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily'}], 'timeFrame': 'Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient expired before completing study'}, {'type': 'SECONDARY', 'title': 'Measure Time (Months) to Progression-free Survival of Patients on Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alliance A031201', 'description': 'Denosumab plus enzalutamide, abiraterone and prednisone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily\n\nAbiraterone: 1000 mg abiraterone by mouth daily\n\nPrednisone: 5 mg prednisone by mouth twice daily'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Denosumab plus enzalutamide alone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily'}], 'timeFrame': 'Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient expired before completing study'}, {'type': 'SECONDARY', 'title': 'Measure Time (Months) to Duration of Response of Patients on Therapy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alliance A031201', 'description': 'Denosumab plus enzalutamide, abiraterone and prednisone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily\n\nAbiraterone: 1000 mg abiraterone by mouth daily\n\nPrednisone: 5 mg prednisone by mouth twice daily'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Denosumab plus enzalutamide alone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily'}], 'timeFrame': 'Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient expired before completing study'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Measure Change in Technetium Bone Scintigraphy on Therapy Via Technetium Bone Scintigraphy or Sodium Fluoride (NaF) PET/CT Imaging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alliance A031201', 'description': 'Denosumab plus enzalutamide, abiraterone and prednisone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily\n\nAbiraterone: 1000 mg abiraterone by mouth daily\n\nPrednisone: 5 mg prednisone by mouth twice daily'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Denosumab plus enzalutamide alone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily'}], 'timeFrame': 'Prior to Registration, Day 1 of cycle 4 and 13, Post-Treatment Follow-up (up to 5 years post treatment)', 'reportingStatus': 'POSTED', 'populationDescription': 'one subject enrolled and they discontinued early from trial, no analysis conducted'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Measure Change in Treatment Response Via RECIST Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alliance A031201', 'description': 'Denosumab plus enzalutamide, abiraterone and prednisone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily\n\nAbiraterone: 1000 mg abiraterone by mouth daily\n\nPrednisone: 5 mg prednisone by mouth twice daily'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Denosumab plus enzalutamide alone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily'}], 'timeFrame': 'Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'one subject enrolled and they discontinued early from trial, no analysis conducted'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Evaluate the Effect of Therapy on Quality of Life (QoL) in Patients Via QoL Questionnaire.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alliance A031201', 'description': 'Denosumab plus enzalutamide, abiraterone and prednisone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily\n\nAbiraterone: 1000 mg abiraterone by mouth daily\n\nPrednisone: 5 mg prednisone by mouth twice daily'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Denosumab plus enzalutamide alone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily'}], 'timeFrame': 'Prior to Registration, Registration, Day 1 of cycle 4 and 13', 'reportingStatus': 'POSTED', 'populationDescription': 'one subject enrolled and they discontinued early from trial, no analysis conducted'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Evaluate the Effect of Therapy on Narcotic Use in Patients on Therapy Via Case Report Forms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alliance A031201', 'description': 'Denosumab plus enzalutamide, abiraterone and prednisone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily\n\nAbiraterone: 1000 mg abiraterone by mouth daily\n\nPrednisone: 5 mg prednisone by mouth twice daily'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Denosumab plus enzalutamide alone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily'}], 'timeFrame': 'Prior to Registration, Registration, Day 1 of cycle 4 and 13', 'reportingStatus': 'POSTED', 'populationDescription': 'one subject enrolled and they discontinued early from trial, no analysis conducted'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alliance A031201', 'description': 'Denosumab plus enzalutamide, abiraterone and prednisone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily\n\nAbiraterone: 1000 mg abiraterone by mouth daily\n\nPrednisone: 5 mg prednisone by mouth twice daily'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Denosumab plus enzalutamide alone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alliance A031201', 'description': 'Denosumab plus enzalutamide, abiraterone and prednisone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily\n\nAbiraterone: 1000 mg abiraterone by mouth daily\n\nPrednisone: 5 mg prednisone by mouth twice daily'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Denosumab plus enzalutamide alone\n\nDenosumab: One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.\n\nEnzalutamide: 160 mg enzalutamide by mouth daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Patient expired before completing study'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Low accruals', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2016-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2016-04-11', 'resultsFirstSubmitDate': '2019-09-10', 'studyFirstSubmitQcDate': '2016-04-29', 'lastUpdatePostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-10', 'studyFirstPostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Measure Change in Technetium Bone Scintigraphy on Therapy Via Technetium Bone Scintigraphy or Sodium Fluoride (NaF) PET/CT Imaging', 'timeFrame': 'Prior to Registration, Day 1 of cycle 4 and 13, Post-Treatment Follow-up (up to 5 years post treatment)'}, {'measure': 'Measure Change in Treatment Response Via RECIST Criteria', 'timeFrame': 'Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment'}, {'measure': 'Evaluate the Effect of Therapy on Quality of Life (QoL) in Patients Via QoL Questionnaire.', 'timeFrame': 'Prior to Registration, Registration, Day 1 of cycle 4 and 13'}, {'measure': 'Evaluate the Effect of Therapy on Narcotic Use in Patients on Therapy Via Case Report Forms.', 'timeFrame': 'Prior to Registration, Registration, Day 1 of cycle 4 and 13'}], 'primaryOutcomes': [{'measure': 'Measure Change in Serum-based Metabolites Associated With Bone Deposition, Growth and Turnover in Patients Who Have CRPC With Clinical Evidence of Metastatic Disease to the Bone, All Using Gas Chromatography-time-of-flight Mass Spectrometry (GC-TOFMS).', 'timeFrame': 'Prior to Registration, Registration, Day 1 of cycle 4 and 13'}], 'secondaryOutcomes': [{'measure': 'Measure Time (Months) to Skeletal Related Event (SRE) of Patients on Therapy', 'timeFrame': 'Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment'}, {'measure': 'Measure Time (Months) to Progression-free Survival of Patients on Therapy', 'timeFrame': 'Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment'}, {'measure': 'Measure Time (Months) to Duration of Response of Patients on Therapy.', 'timeFrame': 'Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Castrate-resistant prostate cancer with bone metastases'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is a correlative study to characterize serum metabolites associated with bone deposition, growth and turnover in patients with newly diagnosed metastatic CRPC who are not currently receiving bone targeting agents.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologic proof of adenocarcinoma of the prostate with clinical evidence of metastatic disease to the bone.\n* Castrate resistant progression of prostate carcinoma, as shown by:\n\n * Serum testosterone level \\<50 ng/dL or prior bilateral orchiectomy. Treatment to maintain castrate levels of testosterone should continue, and\n\n * Either symptomatic progression, or, if patient is asymptomatic then a rising serum PSA in two occasions at least 1 week apart, with minimum pre-treatment serum PSA of 5 ng/dL.\n* Patients with nodal disease are eligible.\n* Bi-dimensionally measurable disease within the bone.\n* Life expectancy of at least 12 weeks.\n* ECOG Performance status \\< 2\n* Adequate:\n\n * Bone marrow function; absolute neutrophil count \\> 1,500 mm3, platelet count of \\> 100,000 mm3 and hemoglobin \\> 9.0 gm/dl.\n * Hepatic function; SGOT/SGPT and conjugated bilirubin less than twice the upper limit of normal.\n * Renal function; serum creatinine ≤ 2 mg/dL (or, if creatinine \\> 2 mg/dL, then a creatinine clearance of at least 35 ml/min (measured or estimated by the Cockroft formula:\n\nCLcr = \\[(140-age) x wt (kg)\\]/\\[72 x serum creatinine (mg/dL)\\].\n\n* No evidence of coagulopathy as indicated by PT \\< 1.5X upper limit of normal.\n* Serum calcium (corrected) from 8 to11.5 mg/dL (2 to 2.9 mmol/L) - Patients must sign an informed consent indicating that they are aware of the investigational nature of the study.\n\nExclusion Criteria:\n\n* Patients with variant histologies (e.g., ductal or small cell carcinoma).\n* Patients with visceral disease are ineligible.\n* Patients who have had prior Sipuleucel-T, docetaxel, cabazitaxel, abiraterone or enzalutamide as a single agent, or in combination therapy.\n* Concurrent cancer chemotherapy, radiotherapy or surgery.\n* Concurrent serious infection.\n* Life threatening illness (e.g., congestive heart failure, uncontrolled angina or myocardial infarction in the prior six months).\n* Hypertension uncontrolled by medication.\n* Patients who are known to require invasive dental procedures.\n* No known or suspected brain metastases (NOTE: patients with treated epidural disease are allowed)\n* Administration of any investigational drug within 28 days prior to receipt of denosumab.\n* Age ≤ 18 years of age'}, 'identificationModule': {'nctId': 'NCT02758132', 'briefTitle': 'Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases', 'organization': {'class': 'OTHER', 'fullName': 'University of Hawaii'}, 'officialTitle': 'Denosumab Plus Enzalutamide, Abiraterone and Prednisone Compared to Denosumab Plus Enzalutamide Alone for Men With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastases: Clinical Testing and Feasibility of a Serum-based Metabolomics Profile', 'orgStudyIdInfo': {'id': 'Rosser 2015-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Alliance A031201', 'description': 'Denosumab plus enzalutamide, abiraterone and prednisone', 'interventionNames': ['Biological: Denosumab', 'Drug: Enzalutamide', 'Drug: Abiraterone', 'Drug: Prednisone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Denosumab plus enzalutamide alone', 'interventionNames': ['Biological: Denosumab', 'Drug: Enzalutamide']}], 'interventions': [{'name': 'Denosumab', 'type': 'BIOLOGICAL', 'description': 'One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.', 'armGroupLabels': ['Alliance A031201', 'Standard of Care']}, {'name': 'Enzalutamide', 'type': 'DRUG', 'description': '160 mg enzalutamide by mouth daily', 'armGroupLabels': ['Alliance A031201', 'Standard of Care']}, {'name': 'Abiraterone', 'type': 'DRUG', 'description': '1000 mg abiraterone by mouth daily', 'armGroupLabels': ['Alliance A031201']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': '5 mg prednisone by mouth twice daily', 'armGroupLabels': ['Alliance A031201']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'University of Hawaii Cancer Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hawaii', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}