Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2026-02-24 @ 9:42 AM
Study NCT ID:
NCT03016312
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2017-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064129', 'term': 'Prostatic Neoplasms, Castration-Resistant'}], 'ancestors': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'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': 'C000594389', 'term': 'atezolizumab'}, {'id': 'C540278', 'term': 'enzalutamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period.", 'description': '4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment.\n\nThe Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively).\n\n759 participants who were randomized are included in the At Risk Population for All Cause Mortality.', 'eventGroups': [{'id': 'EG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.', 'otherNumAtRisk': 374, 'deathsNumAtRisk': 379, 'otherNumAffected': 339, 'seriousNumAtRisk': 374, 'deathsNumAffected': 219, 'seriousNumAffected': 139}, {'id': 'EG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.', 'otherNumAtRisk': 376, 'deathsNumAtRisk': 380, 'otherNumAffected': 309, 'seriousNumAtRisk': 376, 'deathsNumAffected': 191, 'seriousNumAffected': 87}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 98, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 58, 'numAffected': 49}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 88, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 65, 'numAffected': 62}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 109, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 51, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 95, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 73, 'numAffected': 66}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 35, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 35, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 99, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 68, 'numAffected': 63}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 148, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 116, 'numAffected': 103}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 38, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 31, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 37, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 54, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 33, 'numAffected': 32}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 129, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 120, 'numAffected': 104}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 108, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 94, 'numAffected': 64}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 98, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 63, 'numAffected': 55}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 31, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 38, 'numAffected': 34}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 32, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 46, 'numAffected': 39}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 27, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 34, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 30, 'numAffected': 29}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 43, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 59, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 33, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 27, 'numAffected': 19}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Heparin-induced thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Autoimmune myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Deafness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 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'MedDRA 22.0'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Postoperative abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 374, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 376, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '17.0'}, {'value': '16.6', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '18.4'}]}]}], 'analyses': [{'pValue': '0.0940', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.184', 'ciLowerLimit': '0.971', 'ciUpperLimit': '1.445', 'groupDescription': 'Unstratified Analysis', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2786', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.118', 'ciLowerLimit': '0.913', 'ciUpperLimit': '1.370', 'groupDescription': 'Stratified Analysis', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until death from any cause (up to approximately 42 months)', 'description': 'Overall Survival is defined as the time from randomization to death from any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Survived at Month 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}], 'classes': [{'title': '6 Months', 'categories': [{'measurements': [{'value': '85.12', 'groupId': 'OG000', 'lowerLimit': '81.45', 'upperLimit': '88.78'}, {'value': '85.32', 'groupId': 'OG001', 'lowerLimit': '81.67', 'upperLimit': '88.97'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '60.61', 'groupId': 'OG000', 'lowerLimit': '55.52', 'upperLimit': '65.71'}, {'value': '64.65', 'groupId': 'OG001', 'lowerLimit': '59.60', 'upperLimit': '69.70'}]}]}], 'analyses': [{'pValue': '0.9391', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Event Free Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-5.38', 'ciUpperLimit': '4.97', 'groupDescription': 'Difference in Event Free Rate - 6 months', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2706', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Event Free Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.03', 'ciLowerLimit': '-11.21', 'ciUpperLimit': '3.14', 'groupDescription': 'Difference in Event Free Rate - 12 months', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Months 6, 12', 'description': 'OS (Overall Survival is defined as the time from randomization to death from any cause) probability at 6 and 12 months', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to First Symptomatic Skeletal Event (SSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.1', 'comment': 'Due to censoring, the upper limit was not estimable.', 'groupId': 'OG000', 'lowerLimit': '24.1', 'upperLimit': 'NA'}, {'value': '24.9', 'comment': 'Due to censoring, the upper limit was not estimable.', 'groupId': 'OG001', 'lowerLimit': '24.9', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to end of study (up to approximately 42 months)', 'description': 'An SSE is defined as external beam radiation therapy to relieve skeletal symptoms (including initiation of radium-223 dichloride or other types of radionuclide therapy to treat symptoms of bone metastases), new symptomatic pathologic bone fracture, clinically apparent occurrence of spinal cord compression, or tumor related orthopedic surgical intervention.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Radiographic Progression-Free Survival (rPFS), as Assessed by the Investigator and Adapted From the PCWG3 Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '5.3'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '4.5'}]}]}], 'analyses': [{'pValue': '0.3157', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.917', 'ciLowerLimit': '0.775', 'ciUpperLimit': '1.086', 'groupDescription': 'Unstratified Analysis', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2366', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.899', 'ciLowerLimit': '0.754', 'ciUpperLimit': '1.072', 'groupDescription': 'Stratified Analysis', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression or death from any cause (up to approximately 42 months)', 'description': 'rPFS is defined as the time from randomization to the earliest occurrence of one of the following:\n\n* A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed \\< 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented.\n* Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1\n* Death from any cause', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}], 'classes': [{'title': '6 months', 'categories': [{'measurements': [{'value': '41.84', 'groupId': 'OG000', 'lowerLimit': '36.09', 'upperLimit': '47.60'}, {'value': '39.64', 'groupId': 'OG001', 'lowerLimit': '33.86', 'upperLimit': '45.42'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '14.89', 'groupId': 'OG000', 'lowerLimit': '10.74', 'upperLimit': '19.05'}, {'value': '13.45', 'groupId': 'OG001', 'lowerLimit': '9.42', 'upperLimit': '17.49'}]}]}], 'analyses': [{'pValue': '0.5959', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Event Free Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.21', 'ciLowerLimit': '-5.95', 'ciUpperLimit': '10.37', 'groupDescription': 'Difference in Event Free Rate - 6 months', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6262', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Event Free Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.44', 'ciLowerLimit': '-4.35', 'ciUpperLimit': '7.23', 'groupDescription': 'Difference in Event Free Rate - 12 months', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Months 6, 12', 'description': 'rPFS is defined as the time from randomization to the earliest occurrence of one of the following:\n\n* A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed \\< 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented.\n* Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1\n* Death from any cause', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Greater Than (>) 50 Percent (%) Decrease in Prostate-Specific Antigen (PSA) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'groupId': 'OG000', 'lowerLimit': '21.5', 'upperLimit': '30.5'}, {'value': '24.2', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '28.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in 50% Decrease Response Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '2', 'paramValue': '1.6', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '7.8', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': 'Odds Ratio: 1.1 95%CI: 0.8, 1.5'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until disease progression (up to approximately 42 months)', 'description': 'PSA response rate, defined as a \\> 50% decrease in PSA from baseline that is confirmed after ≥ 3 weeks by a consecutive confirmatory PSA measurement', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to PSA Progression, Assessed as Per PCWG3 Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '2.9'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '2.9'}]}]}], 'analyses': [{'pValue': '0.5359', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.055', 'ciLowerLimit': '0.890', 'ciUpperLimit': '1.251', 'groupDescription': 'Unstratified Analysis', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6857', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.037', 'ciLowerLimit': '0.869', 'ciUpperLimit': '1.238', 'groupDescription': 'Stratified Analysis', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline until disease progression (up to approximately 42 months)', 'description': 'In participants with no PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the baseline value, ≥12 weeks after baseline. In participants with an initial PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥3 weeks later.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants in the ITT population with measurable soft tissue lesions at baseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participant With Objective Response, as Determined by the Investigator Through Use of PCWG3 Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '20.7'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '13.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until disease progression or death from any cause (up to approximately 42 months)', 'description': 'Objective response rate in soft tissue lesions, defined as the percentage of participants with either a CR or PR on two consecutive occasions ≥ 6 weeks apart, as determined by the investigator through use of PCWG3 criteria', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '* Participants were classified as missing or unevaluable if no post-baseline response assessments were available or all post-baseline response baseline assessments were unevaluable.\n* Responders had to have a CR or PR on two consecutive occasions at least 6 weeks apart.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}], 'classes': [{'title': 'Total number of participants with at least one adverse event', 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000'}, {'value': '92.3', 'groupId': 'OG001'}]}]}, {'title': 'Total number of participants with at least one treatment related AE', 'categories': [{'measurements': [{'value': '78.1', 'groupId': 'OG000'}, {'value': '51.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of study (up to approximately 42 month)', 'description': 'Verbatim description of adverse events will be coded to MedDRA preferred terms and graded according to NCI CTCAE v4.0.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population is defined as participants who received any amount of any component of the study treatments (atezolizumab, or enzalutamide). Participants will be allocated to treatment arms according to the treatment they actually received (i.e., participants randomized to enzalutamide alone who received at least one full or partial dose of atezolizumab will be included in the atezolizumab arm for safety)'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Serum Concentration (Cmin) of Atezolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1, Day 1, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2, Day 1, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.4', 'spread': '69.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3, Day 1, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '124', 'spread': '79.5', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4, Day 1, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '147', 'spread': '65.1', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 8, Day 1, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '157', 'spread': '305.9', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 12, Day 1, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '155', 'spread': '497.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 16, Day 1, pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '137', 'spread': '144.9', 'groupId': 'OG000'}]}]}, {'title': 'Safety visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.69', 'spread': '1759.3', 'groupId': 'OG000'}]}]}, {'title': 'Study Completion/Early Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.3', 'spread': '1008.1', 'groupId': 'OG000'}]}]}, {'title': 'Study Completion/Early Discontinuation pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.3', 'spread': '106.9', 'groupId': 'OG000'}]}]}, {'title': 'Unscheduled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.5', 'spread': 'NA', 'comment': 'There was only 1 patient for Cmin Unscheduled visit, therefore CV% mean cannot be calculated.', 'groupId': 'OG000'}]}]}, {'title': 'Unscheduled Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.9', 'spread': '326.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-infusion (0 hour[hr]) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); treatment discontinuation visit, 120 days after last dose (up to approximately 42 months)', 'description': "Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing.", 'unitOfMeasure': 'microgram/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population. This population is defined as all randomized participants regardless of whether the assigned study treatment was received. For PK analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax) of Atezolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '365', 'spread': '26.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day Cycle 1 Day 1 0.5 hr post-infusion (infusion duration: 60 minutes [min])', 'description': "Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing.", 'unitOfMeasure': 'Microgram/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population. This population is defined as all randomized participants regardless of whether the assigned study treatment was received. For PK analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Enzalutamide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1 Day 1 Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 1 1 Hr Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.51', 'spread': '406.4', 'groupId': 'OG000'}, {'value': '2.42', 'spread': '270.6', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1 Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': '29.0', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '20.7', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1 1 Hr Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.2', 'spread': '27.3', 'groupId': 'OG000'}, {'value': '16.0', 'spread': '19.8', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8 Day 1 Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.3', 'spread': '103.7', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '30.5', 'groupId': 'OG001'}]}]}, {'title': 'Unscheduled Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': 'NA', 'comment': 'There was only one patient at unscheduled predose visit, therefore no Geometric Coefficient of Variation values can be calculated', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8', 'description': "Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing.", 'unitOfMeasure': 'Microgram/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of N-Desmethyl Enzalutamide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}], 'classes': [{'title': 'Cycle 1 Day 1 Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 1 1 Hr Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': 'NA', 'comment': 'N/A represents data that are not evaluable. Lower Than Reportable data.', 'groupId': 'OG000'}, {'value': '0.03', 'spread': 'NA', 'comment': 'N/A represents data that are not evaluable. Lower Than Reportable data.', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1 Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.9', 'spread': '33.1', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '28.8', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1 1 Hr Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.6', 'spread': '34.2', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '29.8', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8 Day 1 Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.8', 'spread': '36.8', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '32.6', 'groupId': 'OG001'}]}]}, {'title': 'Unscheduled Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.3', 'spread': 'NA', 'comment': 'There was only one patient at unscheduled predose visit, therefore no Geometric Coefficient of Variation values can be calculated', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8', 'description': "Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing.", 'unitOfMeasure': 'Microgram/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}], 'classes': [{'title': 'With Positive Sample at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Without Positive Sample at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '368', 'groupId': 'OG000'}]}]}, {'title': 'Participants positive for Treatment Emergent ADA: treatment induced', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Participants positive for Treatment Emergent ADA: treatment enhanced', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Participants negative for Treatment Emergent ADA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '320', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Predose (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); at atezolizumab discontinuation visit (30 days after last dose); 120 days after last dose of atezolizumab; up to 42 months', 'description': 'The numbers and proportions of ADA-positive participants and ADA-negative participants at baseline (baseline prevalence) and after baseline (post-baseline incidence) will be summarized by treatment group.\n\nEnzalutamide Arm has no Atezolizumab dosing therefore no participants to include here for Atezolizumab ADA.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population is defined as participants who received any amount of any component of the study treatments (atezolizumab, or enzalutamide). Participants will be allocated to treatment arms according to the treatment they actually received (i.e., participants randomized to enzalutamide alone who received at least one full or partial dose of atezolizumab will be included in the atezolizumab arm for safety).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'FG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'participants randomized', 'groupId': 'FG000', 'numSubjects': '379'}, {'comment': 'participants randomized', 'groupId': 'FG001', 'numSubjects': '380'}]}, {'type': 'Participants Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '375'}, {'groupId': 'FG001', 'numSubjects': '375'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '362'}, {'groupId': 'FG001', 'numSubjects': '370'}]}], 'dropWithdraws': [{'type': 'discontinued before the treatment started', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': "Terminated by the Sponsor's decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '184'}]}, {'type': 'loss to contact', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'started a new cancer therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study was conducted at 155 centres in 21 countries.', 'preAssignmentDetails': 'Total 759 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'BG000'}, {'value': '380', 'groupId': 'BG001'}, {'value': '759', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Atezolizumab + Enzalutamide', 'description': 'Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'BG001', 'title': 'Enzalutamide', 'description': 'Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '282', 'groupId': 'BG000'}, {'value': '290', 'groupId': 'BG001'}, {'value': '572', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '70.6', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '70.5', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '379', 'groupId': 'BG000'}, {'value': '380', 'groupId': 'BG001'}, {'value': '759', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '337', 'groupId': 'BG000'}, {'value': '345', 'groupId': 'BG001'}, {'value': '682', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '279', 'groupId': 'BG000'}, {'value': '287', 'groupId': 'BG001'}, {'value': '566', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Total randomised participants 759.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-14', 'size': 1669534, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-05T17:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 759}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2017-01-09', 'resultsFirstSubmitDate': '2021-04-05', 'studyFirstSubmitQcDate': '2017-01-09', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-05', 'studyFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline until death from any cause (up to approximately 42 months)', 'description': 'Overall Survival is defined as the time from randomization to death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Survived at Month 6 and 12', 'timeFrame': 'Months 6, 12', 'description': 'OS (Overall Survival is defined as the time from randomization to death from any cause) probability at 6 and 12 months'}, {'measure': 'Time to First Symptomatic Skeletal Event (SSE)', 'timeFrame': 'Baseline up to end of study (up to approximately 42 months)', 'description': 'An SSE is defined as external beam radiation therapy to relieve skeletal symptoms (including initiation of radium-223 dichloride or other types of radionuclide therapy to treat symptoms of bone metastases), new symptomatic pathologic bone fracture, clinically apparent occurrence of spinal cord compression, or tumor related orthopedic surgical intervention.'}, {'measure': 'Radiographic Progression-Free Survival (rPFS), as Assessed by the Investigator and Adapted From the PCWG3 Criteria', 'timeFrame': 'Baseline until disease progression or death from any cause (up to approximately 42 months)', 'description': 'rPFS is defined as the time from randomization to the earliest occurrence of one of the following:\n\n* A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed \\< 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented.\n* Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1\n* Death from any cause'}, {'measure': 'Percentage of Participants Who Are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria', 'timeFrame': 'Months 6, 12', 'description': 'rPFS is defined as the time from randomization to the earliest occurrence of one of the following:\n\n* A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed \\< 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented.\n* Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1\n* Death from any cause'}, {'measure': 'Percentage of Participants With Greater Than (>) 50 Percent (%) Decrease in Prostate-Specific Antigen (PSA) From Baseline', 'timeFrame': 'Baseline until disease progression (up to approximately 42 months)', 'description': 'PSA response rate, defined as a \\> 50% decrease in PSA from baseline that is confirmed after ≥ 3 weeks by a consecutive confirmatory PSA measurement'}, {'measure': 'Time to PSA Progression, Assessed as Per PCWG3 Criteria', 'timeFrame': 'Baseline until disease progression (up to approximately 42 months)', 'description': 'In participants with no PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the baseline value, ≥12 weeks after baseline. In participants with an initial PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥3 weeks later.'}, {'measure': 'Percentage of Participant With Objective Response, as Determined by the Investigator Through Use of PCWG3 Criteria', 'timeFrame': 'Baseline until disease progression or death from any cause (up to approximately 42 months)', 'description': 'Objective response rate in soft tissue lesions, defined as the percentage of participants with either a CR or PR on two consecutive occasions ≥ 6 weeks apart, as determined by the investigator through use of PCWG3 criteria'}, {'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': 'Baseline up to end of study (up to approximately 42 month)', 'description': 'Verbatim description of adverse events will be coded to MedDRA preferred terms and graded according to NCI CTCAE v4.0.'}, {'measure': 'Minimum Observed Serum Concentration (Cmin) of Atezolizumab', 'timeFrame': 'Pre-infusion (0 hour[hr]) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); treatment discontinuation visit, 120 days after last dose (up to approximately 42 months)', 'description': "Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing."}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of Atezolizumab', 'timeFrame': 'Day Cycle 1 Day 1 0.5 hr post-infusion (infusion duration: 60 minutes [min])', 'description': "Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing."}, {'measure': 'Plasma Concentration of Enzalutamide', 'timeFrame': 'Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8', 'description': "Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing."}, {'measure': 'Plasma Concentration of N-Desmethyl Enzalutamide', 'timeFrame': 'Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8', 'description': "Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing."}, {'measure': 'Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab', 'timeFrame': 'Predose (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); at atezolizumab discontinuation visit (30 days after last dose); 120 days after last dose of atezolizumab; up to 42 months', 'description': 'The numbers and proportions of ADA-positive participants and ADA-negative participants at baseline (baseline prevalence) and after baseline (post-baseline incidence) will be summarized by treatment group.\n\nEnzalutamide Arm has no Atezolizumab dosing therefore no participants to include here for Atezolizumab ADA.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostatic Neoplasms, Castration-Resistant']}, 'referencesModule': {'references': [{'pmid': '35013615', 'type': 'DERIVED', 'citation': 'Powles T, Yuen KC, Gillessen S, Kadel EE 3rd, Rathkopf D, Matsubara N, Drake CG, Fizazi K, Piulats JM, Wysocki PJ, Buchschacher GL Jr, Alekseev B, Mellado B, Karaszewska B, Doss JF, Rasuo G, Datye A, Mariathasan S, Williams P, Sweeney CJ. Atezolizumab with enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer: a randomized phase 3 trial. Nat Med. 2022 Jan;28(1):144-153. doi: 10.1038/s41591-021-01600-6. Epub 2022 Jan 10.'}]}, 'descriptionModule': {'briefSummary': 'This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 \\[anti-PD-L1\\] antibody) in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Life expectancy greater than or equal to (\\>/=) 3 months\n* Histologically confirmed adenocarcinoma of the prostate\n* Known castrate-resistant disease with serum testosterone level less than or equal to (\\</=) 50 nanograms per deciliter (ng/dL) with prior surgical castration or ongoing androgen deprivation for the duration of the study\n* Progressive disease prior to screening by PSA or imaging per PCWG3 criteria during or following the direct prior line of therapy in the setting of medical or surgical castration\n* One prior regimen/line of a taxane-containing regimen for mCRPC or refusal or ineligibility of a taxane-containing regimen\n* Progression on a prior regimen/line of an androgen synthesis inhibitor for prostate cancer\n* Availability of a representative tumor specimen from a site not previously irradiated that is suitable for determination of programmed death-ligand 1 (PD-L1) status via central testing\n* Adequate hematologic and end organ function\n\nExclusion Criteria:\n\n* Prior treatment with enzalutamide or any other newer hormonal androgen receptor inhibitor (e.g., apalutamide, ODM-201)\n* Treatment with any approved anti-cancer therapy, including chemotherapy, immunotherapy, radiopharmaceutical or hormonal therapy (with the exception of abiraterone), within 4 weeks prior to initiation of study treatment\n* Treatment with abiraterone within 2 weeks prior to study treatment\n* Structurally unstable bone lesions suggesting impending fracture\n* Known or suspected brain metastasis or active leptomeningeal disease\n* Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study\n* Active or history of autoimmune disease or immune deficiency\n* Prior allogeneic stem cell or solid organ transplantation\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n* Positive human immunodeficiency virus (HIV) test, active tuberculosis, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n* Prior treatment with cluster of differentiation (CD)137 agonists or immune checkpoint blockade therapies, including anti Cytotoxic T Lymphocyte-Associated 4 (CTLA4), anti-programmed death 1 (PD-1), and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study\n* History of seizure or any condition that may predispose to seizure within 12 months prior to study treatment, including history of unexplained loss of consciousness or transient ischemic attack'}, 'identificationModule': {'nctId': 'NCT03016312', 'acronym': 'IMbassador250', 'briefTitle': 'A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor and Failure of, Ineligibility for, or Refusal of a Taxane Regimen', 'orgStudyIdInfo': {'id': 'CO39385'}, 'secondaryIdInfos': [{'id': '2016-003092-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atezolizumab + Enzalutamide', 'description': 'Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).', 'interventionNames': ['Drug: Atezolizumab', 'Drug: Enzalutamide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enzalutamide', 'description': 'Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).', 'interventionNames': ['Drug: Enzalutamide']}], 'interventions': [{'name': 'Atezolizumab', 'type': 'DRUG', 'otherNames': ['Tecentriq®'], 'description': 'Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg), intravenous (IV) infusion on Day 1 of each 21-day cycle.', 'armGroupLabels': ['Atezolizumab + Enzalutamide']}, {'name': 'Enzalutamide', 'type': 'DRUG', 'otherNames': ['Xtandi®'], 'description': 'Enzalutamide capsules will be administered orally at a dose of 160 mg daily.', 'armGroupLabels': ['Atezolizumab + Enzalutamide', 'Enzalutamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Grp Inc.', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92037-1337', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente San Diego - Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Hematology Oncology Associates', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80021', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado; Division of Medical Oncology', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06510-3206', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06904', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Stamford Hospital; BCC, MOHR', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Lynn Cancer Institute/Boca Raton Regional Hospital', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33916', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'SCRI Florida Cancer Specialists South', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Cancer Institute of Baptist Health, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialist, North Region', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigative Clin Rsch of IN', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Associates in Oncology/Hematology P.C.', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute..', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '68130', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Nebraska Cancer Specialists; Oncology Hematology West, PC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68130', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Urology Cancer Center & GU Research Network', 'geoPoint': {'lat': 41.25626, 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