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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 6:48 PM

Ignite Modification Date: 2026-01-04 @ 6:30 PM

Study NCT ID: NCT00170157

Status: COMPLETED

Last Update Posted: 2017-05-15

First Post: 2005-09-13

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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': 'C053541', 'term': 'bicalutamide'}, {'id': 'D005485', 'term': 'Flutamide'}, {'id': 'D017273', 'term': 'Goserelin'}, {'id': 'D000074324', 'term': 'Ipilimumab'}, {'id': 'D060908', 'term': 'CTLA-4 Antigen'}, {'id': 'D016729', 'term': 'Leuprolide'}, {'id': 'C493311', 'term': 'luprolide acetate gel depot'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'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': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D000082102', 'term': 'Immune Checkpoint Proteins'}, {'id': 'D061025', 'term': 'Costimulatory and Inhibitory T-Cell Receptors'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D000945', 'term': 'Antigens, Differentiation, T-Lymphocyte'}, {'id': 'D000943', 'term': 'Antigens, Differentiation'}, {'id': 'D000954', 'term': 'Antigens, Surface'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D015415', 'term': 'Biomarkers'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kwon.eugene@mayo.edu', 'title': 'Eugene D. Kwon', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Two participants cancelled prior to beginning study treatment, thus did not experience any adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Entire Study Population', 'description': 'All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone the AA Therapy + MDX-010) were grouped together for this outcome.', 'otherNumAtRisk': 110, 'otherNumAffected': 107, 'seriousNumAtRisk': 110, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 34, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Endocrine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Vision-Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 44, 'numAffected': 24}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Anal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Colonic hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Diarrhea-No Colostom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pain-Abdominal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Constitutional Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Edema: Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 160, 'numAffected': 79}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pain-Chest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Rigors', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hepatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Colon infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Lung (pneumonia) infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Penis infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Skin (cellulites) infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Bruising (in absence of grade 3 or 4 thrombocytopenia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 65, 'numAffected': 32}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 69, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Amylase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 55, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 36, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 29, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Metabolic/Lab', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Bicarbonate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 37, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 279, 'numAffected': 87}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 31, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 34, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 61, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Extremity-lower necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Ischemia-Cerebral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Neuro', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 74, 'numAffected': 33}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 171, 'numAffected': 75}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Ureteral Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Urinary bladder hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 42, 'numAffected': 24}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Prostatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Sinus Reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Decubitus Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Nail Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Rash/Desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 29, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 207, 'numAffected': 88}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}], 'seriousEvents': [{'term': 'Ischemia/Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Vision-Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Diarrhea-No Colostom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pain-Abdominal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hepatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Amylase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Rash/Desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 6'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Progression-free at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entire Study Population', 'description': 'All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone) initially randomized (i.e., before cross-over) were grouped together for this outcome.\n\n.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months from the start of AA therapy', 'description': 'PSA progression is defined as a rise in PSA to \\>4.0 ng/mL demonstrated twice in measurements taken two weeks apart.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Undetectable Prostate-specific Antigen (PSA) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Androgen Ablative (AA) Therapy + MDX-010', 'description': '3 months of concurrent androgen ablative (AA) therapy + MDX-010\n\nAndrogen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily.\n\nMDX-010 is received as an infusion at a dose of 3.0 mg/kg on day 7.'}, {'id': 'OG001', 'title': 'Androgen Ablative (AA) Then AA Therapy + MDX-010', 'description': '3 months of initial AA therapy alone\n\nAndrogen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Percent of participants who had undetectable PSA at 3 months on the initially assigned treatment arm (prior to crossing over).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '105 participants had follow-up PSA information; those without a follow-up PSA were excluded from this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Androgen Ablative (AA) Therapy + MDX-010', 'description': '3 months of concurrent androgen ablative (AA) therapy + MDX-010\n\nAndrogen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily.\n\nMDX-010 is received as an infusion at a dose of 3.0 mg/kg on day 7.'}, {'id': 'FG001', 'title': 'Androgen Ablative (AA) Then AA Therapy + MDX-010', 'description': '3 months of initial AA therapy alone\n\nAndrogen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily.'}], 'periods': [{'title': 'Treatment Period 1 Initial Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period of 14 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants initially randomized to this arm were not eligible for crossover.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}, {'title': 'Treatment Period 2 Crossover', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants initially randomized to this arm were not eligible for crossover.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '112 participants were recruited between June 2004 and June 2009 at Mayo Clinic.', 'preAssignmentDetails': 'All participants were initially randomized to either arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'All participants initially randomized.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<= 39', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '40-49', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '50-59', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}, {'title': '60-69', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}, {'title': '>= 70', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '112', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-06', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2013-05-03', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-12-20', 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Progression-free at 18 Months', 'timeFrame': '18 months from the start of AA therapy', 'description': 'PSA progression is defined as a rise in PSA to \\>4.0 ng/mL demonstrated twice in measurements taken two weeks apart.'}], 'secondaryOutcomes': [{'measure': 'Percent of Participants With Undetectable Prostate-specific Antigen (PSA) Response', 'timeFrame': '3 months', 'description': 'Percent of participants who had undetectable PSA at 3 months on the initially assigned treatment arm (prior to crossing over).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Adenocarcinoma', 'Prostate Carcinoma', 'Recurrent Prostate Carcinoma', 'Stage III Prostate Cancer', 'Stage IV Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells.\n\nPURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.', 'detailedDescription': 'OBJECTIVES:\n\nI. To generally test whether the addition of CTLA-4 blockade can enhance clinical treatment response in advance prostate cancer patients compared with treatment with AA therapy alone.\n\nII. To specifically examine whether concomitant AA therapy + MDX-010 can be used to prolong the progression-free interval in advanced prostate cancer patients compared with inductive short-term AA therapy alone.\n\nIII. To specifically examine whether concomitant AA therapy + MDX-010 can be used to enhance initial PSA responses in advanced prostate cancer patients compared with inductive short-term AA therapy alone.\n\nIV. To specifically examine whether delayed MDX-010 can be used to induce PSA response in patients experiencing disease progression following cessation of short-term AA therapy.\n\nV. To generally examine whether MDX-010 enhances host immune response that might be involved in conferring treatment advantages to patients receiving AA therapy.\n\nVI. To specifically examine whether MDX-010 potentiates T-cell responses in advanced prostate cancer patients initiating inductive short-term AA therapy.\n\nVII. To further examine whether treatment induced T-cell responses correlate with clinical response to treatment.\n\nVIII. To examine whether short-term AA there (+/- MDX-010) induces the appearance of newly emigrated T or immature and/or B cells.\n\nOUTLINE:\n\nPatients are randomized to 1 of 2 treatment arms.\n\nARM I: Patients receive either leuprolide acetate intramuscularly (IM) or goserelin subcutaneously (SC) on days 0, 28, and 56. Patients also receive oral flutamide three times daily or oral bicalutamide once daily. Treatment with antiandrogen (AA) therapy continues for 3 months (3-4 months for patients who initiated AA therapy \\<= 21 days prior to enrollment) in the absence of disease progression or unacceptable toxicity. Patients receive ipilimumab IV over 90 minutes on day 7 (within 7-28 days post-initiation of AA therapy for patients who initiated AA therapy \\<= 21 days prior to enrollment) of AA therapy.\n\nArm II: Patients receive AA therapy as in arm I. Patients may crossover to arm II in the case of disease progression.\n\nAfter completion of study treatment, patients are followed periodically.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NOTE: All values must be obtained =\\< 14 prior to study entry\n* Histologically confirmed adenocarcinoma of the prostate staged within 180 days of study enrollment, \\>cT2cN0/M0 stage with or without metastatic disease, with the exclusion of central nervous system (CNS) metastases; includes post radical prostatectomy patients with a rising PSA\n* An initial PSA \\>= 4.0 ng/mL (Hybritech Assay)\n* For those patients who have received hormone therapy =\\< 21 days, a documented PSA of \\>= 4.0 prior to initiation of hormone therapy is acceptable.\n* For patients who are post radical prostatectomy, a rising PSA is acceptable.\n* Adequate organ function defined as: WBC \\>= 3,000/uL; platelets \\>= 75,000/uL; total bilirubin =\\< 1.5 mg/dL; transaminases =\\< 2.5 x upper limit of normal (ULN); serum creatine =\\< 2.0 mg/dL or calculated creatinine clearance \\>= 60 mL/min\n* ECOG performance status of 0-2\n* Able to understand and sign informed consent\n\nExclusion Criteria:\n\n* Underlying other serious medical condition which, in the opinion of the investigator precludes study participation; this includes immune-suppressive disease such as AIDS or autoimmune disorders such as multiple sclerosis, lupus, or myasthenia gravis\n* Patients not recovered from major infections and/or surgical procedures\n* Prior hormonal therapy \\> 21 days prior to enrollment, including estrogens, LH/RH agonists, or antiandrogens\n* Recent (=\\< 3 months of informed consent) usage of immune-suppressive medication including steroids, Immuran, Cyclosporin; topical or inhalational steroid use is permissible\n* Prior systemic chemotherapy\n* Prior radiation therapy to the prostate\n* Prior malignancy, unless the patient has been cancer-free for five years or more\n* Uncontrolled underlying medical or psychiatric illness, or serious active infections\n* Patient unwilling to complete all required follow-up visits\n* History of motor neuropathy considered of the autoimmune origin (e.g. Guillian-Barre Syndrome)\n* Concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer\n* For patients who elect to undergo the baseline transrectal needle biopsy of the prostate, current usage of systemic anticoagulation therapy, i.e. heparin or Coumadin or inability to discontinue aspirin, aspirin-containing products or ibuprofen for seven days prior to the prostate biopsies required for this study\n* No other investigational drugs will be allowed during the study\n* Other chemotherapy, radiation therapy, immunotherapy, hormonal therapy, or biologic therapy may not be used while the patient is on study'}, 'identificationModule': {'nctId': 'NCT00170157', 'briefTitle': 'Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Phase II Immunotherapeutic Trial: Combination Androgen Ablative Therapy and CTLA-4 Blockade as a Treatment for Advanced Prostate Cancer', 'orgStudyIdInfo': {'id': 'MC0253'}, 'secondaryIdInfos': [{'id': 'NCI-2009-01214', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'MC0253', 'type': 'OTHER', 'domain': 'Mayo Clinic'}, {'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive either leuprolide acetate intramuscularly (IM) or goserelin subcutaneously (SC) on days 0, 28, and 56. Patients also receive oral flutamide three times daily or oral bicalutamide once daily. Treatment with antiandrogen (AA) therapy continues for 3 months (3-4 months for patients who initiated AA therapy \\<= 21 days prior to enrollment) in the absence of disease progression or unacceptable toxicity. Patients receive ipilimumab IV over 90 minutes on day 7 (within 7-28 days post-initiation of AA therapy for patients who initiated AA therapy \\<= 21 days prior to enrollment) of AA therapy.', 'interventionNames': ['Drug: Bicalutamide', 'Drug: Flutamide', 'Drug: Goserelin Acetate', 'Drug: Ipilimumab', 'Drug: Leuprolide Acetate', 'Other: Pharmacological Study']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II', 'description': 'Patients receive AA therapy as in arm I. Patients may crossover to arm II in the case of disease progression.', 'interventionNames': ['Drug: Bicalutamide', 'Drug: Flutamide', 'Drug: Leuprolide Acetate', 'Other: Pharmacological Study']}], 'interventions': [{'name': 'Bicalutamide', 'type': 'DRUG', 'otherNames': ['Casodex', 'Cosudex', 'ICI 176,334', 'ICI 176334'], 'description': 'Given orally', 'armGroupLabels': ['Arm I', 'Arm II']}, {'name': 'Flutamide', 'type': 'DRUG', 'otherNames': ["4'-Nitro-3'-trifluoromethylisobutyranilide", 'Apimid', 'Chimax', 'Drogenil', 'Euflex', 'Eulexin', 'Eulexine', 'Flucinom', 'Flucinome', 'Flugerel', 'Fluken', 'Flulem', 'FLUT', 'Fluta-Gry', 'Flutabene', 'Flutacan', 'Flutamex', 'Flutamin', 'Flutan', 'Flutaplex', 'Fugerel', 'Grisetin', 'Niftolid', 'Oncosal', 'Profamid', 'Prostacur', 'Prostadirex', 'Prostica', 'Prostogenat', 'SCH 13521', 'Tafenil', 'Tecnoflut', 'Testotard'], 'description': 'Given orally', 'armGroupLabels': ['Arm I', 'Arm II']}, {'name': 'Goserelin Acetate', 'type': 'DRUG', 'otherNames': ['ZDX', 'Zoladex'], 'description': 'Given SC', 'armGroupLabels': ['Arm I']}, {'name': 'Ipilimumab', 'type': 'DRUG', 'otherNames': ['Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody', 'BMS-734016', 'MDX-010', 'MDX-CTLA4', 'Yervoy'], 'description': 'Given IV', 'armGroupLabels': ['Arm I']}, {'name': 'Leuprolide Acetate', 'type': 'DRUG', 'otherNames': ['A-43818', 'Abbott 43818', 'Abbott-43818', 'Carcinil', 'Depo-Eligard', 'Eligard', 'Enanton', 'Enantone', 'Enantone-Gyn', 'Ginecrin', 'LEUP', 'Leuplin', 'Leuprorelin Acetate', 'Lucrin', 'Lucrin Depot', 'Lupron', 'Lupron Depot', 'Lupron Depot-3 Month', 'Lupron Depot-4 Month', 'Lupron Depot-Ped', 'Procren', 'Procrin', 'Prostap', 'TAP-144', 'Trenantone', 'Uno-Enantone', 'Viadur'], 'description': 'Given IM', 'armGroupLabels': ['Arm I', 'Arm II']}, {'name': 'Pharmacological Study', 'type': 'OTHER', 'description': 'Correlative study', 'armGroupLabels': ['Arm I', 'Arm II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Eugene Kwon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}