Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-04 @ 11:44 PM
Study NCT ID:
NCT02903160
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2016-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration Resistant Prostate Cancer (CRPC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069501', 'term': 'Abiraterone Acetate'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'C581106', 'term': 'radium Ra 223 dichloride'}, {'id': 'C552428', 'term': 'cabazitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'C540278', 'term': 'enzalutamide'}], 'ancestors': [{'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bobby.liaw@mountsinai.org', 'phone': '212-604-6010', 'title': 'Dr. Bobby Liaw', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed from enrollment up to 48 weeks. All-Cause Mortality was from first dose until death, assessed up to 47.8 months', 'eventGroups': [{'id': 'EG000', 'title': 'Intensive, Non-Cross Reactive Therapy', 'description': 'Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 18, 'seriousNumAtRisk': 33, 'deathsNumAffected': 1, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 7}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'white blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'muscle cramp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'muscle weakness lower limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'hyperhydrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'maculopapular rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'urinary tract pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive, Non-Cross Reactive Therapy', 'description': 'Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '23.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '47.8 months', 'description': 'Time to disease progression, as determined by either PSA or radiographic progression, after completion of all modules of the rapidly-cycling, non-cross reactive regimen in patients with mCRPC.\n\nTime to progression (TTP) is defined as beginning with the time the first dose of PCD regimen is administered until disease progression.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive, Non-Cross Reactive Therapy', 'description': 'Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median OS not reached. Not enough events that have occurred to have a median OS. Not enough event data to estimate the lower and the upper bound of the 95% CI for median OS.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '47.8 months', 'description': 'Overall survival defined as the time of study entry to death from any cause.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Rate of Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive, Non-Cross Reactive Therapy', 'description': 'Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '47', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '40 months', 'description': 'Overall rate of survival at 40 months. Overall rate of Survival as defined by likelihood that a participant on the study is still alive at 40 months follow up', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With PSA Response Rate >90%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive, Non-Cross Reactive Therapy', 'description': 'Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day'}], 'classes': [{'title': 'after module 1, 12 weeks', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'after module 2, 24 weeks', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'after module 3, 36 weeks', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 36 weeks', 'description': 'PSA response rate - \\>90% decrease in PSA compared to baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With PSA Response Rate >=50%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive, Non-Cross Reactive Therapy', 'description': 'Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day'}], 'classes': [{'title': 'after module 1, 12 weeks', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'after module 2, 24 weeks', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'after module 3, 36 weeks', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 36 weeks', 'description': 'Number of participants with PSA response rate \\>=50% decrease in PSA compared to baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With PSA Progression Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive, Non-Cross Reactive Therapy', 'description': 'Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day'}], 'classes': [{'title': 'after module 1, 12 weeks', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'after module 2, 24 weeks', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'after module 3, 36 weeks', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 36 weeks', 'description': 'PSA changes was reported globally using a waterfall plot for each module. In participants who have a decline in PSA value from baseline, progression is defined by:\n\n* An increase in PSA by 25% above the nadir, AND\n* An increase in PSA by a minimum of 2 ng/ml, or an increase in PSA to the pre-treatment PSA value, AND\n* Confirmation by a second PSA at least 3 weeks apart, AND\n* Occur following at least 12 weeks of therapy, AND\n* There is no objective evidence of disease response.\n\nIn participants whose PSA value from baseline has not declined from baseline, progression is defined by:\n\n* An increase in PSA by 25% above either the pre-treatment level, or the nadir PSA level (whichever is lowest), AND\n* An increase in PSA by a minimum of 2 ng/ml, AND\n* Confirmation by a second PSA at least 3 weeks apart, AND\n* Occur following at least 12 weeks of therapy, AND\n* There is no objective evidence of disease response.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stable PSA as Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive, Non-Cross Reactive Therapy', 'description': 'Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day'}], 'classes': [{'title': 'after module 1, 12 weeks', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'after module 2, 24 weeks', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'after module 3, 36 weeks', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 36 weeks', 'description': 'Participants with a 50% PSA decline from their baseline PSA level will be considered responders, provided objective tumor measurements are stable or also demonstrate response. Participants with a 25% PSA increase from their baseline PSA will be considered nonresponders. Participants that do not meet criteria for responder or nonresponder, will be considered to have stable disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Normal Alkaline Phosphatase Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intensive, Non-Cross Reactive Therapy', 'description': 'Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline and 36 weeks', 'description': 'Number of participants who converted from elevated to normal range of alkaline phosphatase levels at 9 months from baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for those with elevated alkaline phosphatase levels at baseline and with results available at 36 weeks'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intensive, Non-Cross Reactive Therapy', 'description': 'Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Medical Insurance Barriers', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intensive, Non-Cross Reactive Therapy', 'description': 'Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate 1000 mg PO daily; 2. Cabazitaxel 25 mg/m2 IV every 3 weeks + Carboplatin AUC 4 IV every 3 weeks; 3. Enzalutamide 160 mg PO daily + Radium-223 kg IV monthly and Prednisone: 5 mg PO twice a day'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '85'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Amerian Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gleason score', 'classes': [{'title': '<=6', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '7', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': '>=8', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gleason scores ranges from 2-10. A score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer.', 'unitOfMeasure': 'Participants'}, {'title': 'Prostate-specific antigen (PSA)', 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'groupId': 'BG000', 'lowerLimit': '4.8', 'upperLimit': '40.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Alkaline phosphatase', 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000', 'lowerLimit': '77.8', 'upperLimit': '153'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'IU/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Alkaline phosphatase', 'classes': [{'title': 'Elevated (>126 IU/L)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Normal (<=126 IU/L)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG)', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'unknown', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ECOG Performance Status Scale:\n\n0 Fully active, able to carry on all pre-disease performance without restriction\n\n1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work', 'unitOfMeasure': 'Participants'}, {'title': 'Sites of metastasis', 'classes': [{'title': 'Bone', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}, {'title': 'Lymph node', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Lung', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Liver', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-22', 'size': 747439, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-30T14:20', 'hasProtocol': True}, {'date': '2019-05-22', 'size': 441521, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-11-30T14:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2016-09-07', 'resultsFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2016-09-12', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-16', 'studyFirstPostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Disease Progression', 'timeFrame': '47.8 months', 'description': 'Time to disease progression, as determined by either PSA or radiographic progression, after completion of all modules of the rapidly-cycling, non-cross reactive regimen in patients with mCRPC.\n\nTime to progression (TTP) is defined as beginning with the time the first dose of PCD regimen is administered until disease progression.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '47.8 months', 'description': 'Overall survival defined as the time of study entry to death from any cause.'}, {'measure': 'Overall Rate of Survival', 'timeFrame': '40 months', 'description': 'Overall rate of survival at 40 months. Overall rate of Survival as defined by likelihood that a participant on the study is still alive at 40 months follow up'}, {'measure': 'Number of Participants With PSA Response Rate >90%', 'timeFrame': 'up to 36 weeks', 'description': 'PSA response rate - \\>90% decrease in PSA compared to baseline'}, {'measure': 'Number of Participants With PSA Response Rate >=50%', 'timeFrame': 'up to 36 weeks', 'description': 'Number of participants with PSA response rate \\>=50% decrease in PSA compared to baseline'}, {'measure': 'Number of Participants With PSA Progression Compared to Baseline.', 'timeFrame': 'up to 36 weeks', 'description': 'PSA changes was reported globally using a waterfall plot for each module. In participants who have a decline in PSA value from baseline, progression is defined by:\n\n* An increase in PSA by 25% above the nadir, AND\n* An increase in PSA by a minimum of 2 ng/ml, or an increase in PSA to the pre-treatment PSA value, AND\n* Confirmation by a second PSA at least 3 weeks apart, AND\n* Occur following at least 12 weeks of therapy, AND\n* There is no objective evidence of disease response.\n\nIn participants whose PSA value from baseline has not declined from baseline, progression is defined by:\n\n* An increase in PSA by 25% above either the pre-treatment level, or the nadir PSA level (whichever is lowest), AND\n* An increase in PSA by a minimum of 2 ng/ml, AND\n* Confirmation by a second PSA at least 3 weeks apart, AND\n* Occur following at least 12 weeks of therapy, AND\n* There is no objective evidence of disease response.'}, {'measure': 'Number of Participants With Stable PSA as Compared to Baseline', 'timeFrame': 'up to 36 weeks', 'description': 'Participants with a 50% PSA decline from their baseline PSA level will be considered responders, provided objective tumor measurements are stable or also demonstrate response. Participants with a 25% PSA increase from their baseline PSA will be considered nonresponders. Participants that do not meet criteria for responder or nonresponder, will be considered to have stable disease.'}, {'measure': 'Number of Participants With Normal Alkaline Phosphatase Levels', 'timeFrame': 'baseline and 36 weeks', 'description': 'Number of participants who converted from elevated to normal range of alkaline phosphatase levels at 9 months from baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Castration resistant', 'Prostate cancer', 'Metastatic', 'First-line', 'Treatment naive', 'Rapidly cycling', 'Non-cross resistant'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the clinical benefits of using a rapidly cycling, non-cross reactive regimen of FDA-approved prostate cancer therapeutic agents in the management of castration resistant prostate cancer. The hypothesis is that the identification of optimal combinations and sequencing of therapies can help prevent or delay the development of therapeutic drug resistance, and can be safely tolerated.', 'detailedDescription': "This phase II clinical trial will explore the efficacy of rapidly cycling non-cross reactive treatment therapies in the treatment of patients with newly diagnosed mCRPC. The primary hypothesis is that the best chance of eliminating or controlling disease is when the cancer is treatment naïve, and has not yet developed therapeutic resistance. By finding an optimal drug deployment strategy of already approved and available treatments for mCRPC, the researchers believe providers can more effectively treat an intrinsically heterogeneous disease, delay/prevent drug resistance, as well as minimize treatment toxicity.\n\nAll of the treatment agents selected have well-defined individual toxicity profiles from large phase III trials, but there is limited clinical data about the toxicity profiles of these drugs in combinations. While each agent is generally well tolerated, toxicities remain a significant concern given the older age of the typical mCRPC patient, the comorbid conditions common to this patient population, as well as those borne from previous chronic androgen deprivation therapy.\n\nEach drug in the proposed treatment regimen will be used at their FDA-approved dosing and indication, with the exception of cabazitaxel, which will be used prior to disease demonstration of docetaxel failure, and in combination with carboplatin. The proposed sequencing is rationally designed, and based on each drug's distinct mechanisms of action as well as their toxicity profiles.\n\nThe rapidly-cycling treatment regimen contains three, separate, consecutive treatment modules, each lasting 3 months: 1. Abiraterone; 2. Cabazitaxel + Carboplatin; 3. Enzalutamide + Radium-223. Therapeutic agents are delivered as non-cross reactive combinations, in order to achieve optimal therapeutic dosing at each cycle and decrease possibility of significant adverse effects.\n\nTo the researcher knowledge, no study has evaluated the use of rapidly cycling, non-cross reactive therapies for the treatment of mCRPC. The hypothesis is that the identification of optimal combinations and sequencing of rapidly cycling non-cross reactive therapies can help prevent or delay the development of therapeutic drug resistance, and can be safely tolerated.\n\nPrimary objective is to evaluate the time to disease progression after completion of all modules of the rapidly-cycling, non-cross reactive regimen in patients with mCRPC. Secondary objectives are to evaluate overall survival, prostate-specific antigen (PSA) response rate with each treatment module, changes to alkaline phosphatase level, and assess safety of the rapidly-cycling, non-cross reactive regimen. Additional exploratory objective are to evaluate the correlation of a peripheral whole-blood RNA signature with clinical outcome measures during and after treatment, and to evaluate changes to AR-V7 expression in CTCs with different treatment modalities and clinical outcomes."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* Metastatic castrate resistant prostate cancer, defined by progressive disease based on either rising PSA, new bone metastases, or progression of measurable disease on standard imaging, according to PCWG2 guidelines, despite androgen deprivation therapy\n* Ongoing androgen deprivation therapy with a GnRH analogue, GnRH antagonist, or bilateral orchiectomy\n* ECOG performance status 0-1\n* Serum testosterone level \\< 50 ng/dL\n* Absolute neutrophil count \\> 1,500/μL, platelet count \\> 100,000/μL, and hemoglobin \\> 9 g/dL\n* Creatinine \\< 2 mg/dL\n* Total bilirubin \\< 1 times the upper limit of normal, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of normal\n\nExclusion Criteria:\n\n* History of uncontrolled seizure disorder\n* Clinically significant cardiovascular disease including:\n\n 1. Myocardial infarction or uncontrolled angina within 6 months\n 2. Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past\n 3. Uncontrolled hypertension as indicated by a resting systolic blood pressure \\> 170 mmHg or diastolic blood pressure \\> 105 mmHg at the screening visit\n* Have used or plan to use from 30 days prior to enrollment through the end of the study medication known to lower the seizure threshold or prolong the QT interval\n* Major surgery within 4 weeks of enrollment\n* Radiation therapy within 4 weeks of enrollment\n* Prior use of abiraterone acetate, enzalutamide, docetaxel, cabazitaxel, carboplatin, or radium-223 for the treatment of castration-resistant disease\n* Prior docetaxel use in the hormone-sensitive disease setting is allowed, but must be completed ≥ 4 weeks prior to enrollment\n* Prior sipuleucel-T use is allowed, but must be completed ≥ 4 weeks prior to enrollment\n* Concurrent use of zoledronic acid or denosumab is allowed on study'}, 'identificationModule': {'nctId': 'NCT02903160', 'briefTitle': 'Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration Resistant Prostate Cancer (CRPC)', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Clinical Trial of a Rapidly Cycling, Non-Cross Reactive Regimen of Approved Therapeutic Agents to Treat Prostate Cancer', 'orgStudyIdInfo': {'id': 'GCO 16-1593'}, 'secondaryIdInfos': [{'id': 'CABAZL07459', 'type': 'OTHER', 'domain': 'Sanofi'}, {'id': 'ONC-2014-168', 'type': 'OTHER', 'domain': 'Bayer'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive, Non-Cross Reactive Therapy', 'description': 'Prostate Cancer Rapidly cycling, Intensive, Non-Cross Reactive Therapy (PRINT) Rapidly cycling, consecutive treatment modules: 1. Abiraterone acetate; 2. Cabazitaxel + Carboplatin; 3. Enzalutamide + Radium-223', 'interventionNames': ['Drug: Abiraterone acetate', 'Drug: Prednisone', 'Drug: Radium-223 dichloride', 'Drug: cabazitaxel', 'Drug: Carboplatin', 'Drug: Enzalutamide']}], 'interventions': [{'name': 'Abiraterone acetate', 'type': 'DRUG', 'description': 'Abiraterone acetate 1000 mg PO daily', 'armGroupLabels': ['Intensive, Non-Cross Reactive Therapy']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': '5 mg PO twice a day', 'armGroupLabels': ['Intensive, Non-Cross Reactive Therapy']}, {'name': 'Radium-223 dichloride', 'type': 'DRUG', 'description': '50 kBq/kg IV monthly', 'armGroupLabels': ['Intensive, Non-Cross Reactive Therapy']}, {'name': 'cabazitaxel', 'type': 'DRUG', 'description': '25 mg/m2 IV every 3 weeks', 'armGroupLabels': ['Intensive, Non-Cross Reactive Therapy']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin AUC 4 IV every 3 weeks', 'armGroupLabels': ['Intensive, Non-Cross Reactive Therapy']}, {'name': 'Enzalutamide', 'type': 'DRUG', 'description': '160 mg PO daily', 'armGroupLabels': ['Intensive, Non-Cross Reactive Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Beth Israel', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10028', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Bobby Liaw, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}, {'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Profesor', 'investigatorFullName': 'Bobby Liaw', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}