Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-01 @ 9:06 AM
Study NCT ID:
NCT00924469
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
2009-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C089740', 'term': 'abiraterone'}, {'id': 'D000069501', 'term': 'Abiraterone Acetate'}, {'id': 'D016729', 'term': 'Leuprolide'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '(310) 914-2917', 'title': 'Senior Director, Clinical Research', 'organization': 'Janssen Research & Development, LLC 10990 Wilshire Blvd, Suite 1200 Los Angeles, CA 90024'}, 'certainAgreement': {'otherDetails': 'Sponsor will retain the right to review all material prior to presentation or submission for publication and neither institution(s) nor Study Co-Chairs/Principal Investigator(s) is/are permitted to publish/present the results of the study, in part or in their entirety, without the written authorization of the Sponsor. The review is aimed at complying with 21CFR312.7 (non promotion of investigational drugs) as well as the intellectual property rights and commercial interests of the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Week 32', 'description': 'An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.', 'eventGroups': [{'id': 'EG000', 'title': 'Abiraterone Plus Leuprolide Plus Prednisone', 'description': "Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.", 'otherNumAtRisk': 30, 'otherNumAffected': 30, 'seriousNumAtRisk': 30, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone', 'description': 'Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.', 'otherNumAtRisk': 28, 'otherNumAffected': 28, 'seriousNumAtRisk': 28, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Gynaecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Loss of libido', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Mood swings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Urine flow decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Testicular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 27}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}], 'seriousEvents': [{'term': 'Pituitary infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Gastrointestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Hernia obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Infected lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Pituitary tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Testosterone Concentration in Prostate Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abiraterone Plus Leuprolide Plus Prednisone', 'description': "Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks."}, {'id': 'OG001', 'title': 'Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone', 'description': 'Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.089', 'spread': '0.0637', 'groupId': 'OG000'}, {'value': '0.228', 'spread': '0.3788', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0216', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '0.61', 'ciLowerLimit': '0.429', 'ciUpperLimit': '0.865', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using two-way analysis of variance (ANOVA) adjusting for Baseline risk factor.', 'groupDescription': 'Statistical Analysis 1 for testosterone concentration at Week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12.', 'unitOfMeasure': 'Picogram per milligram (pg/mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat (ITT) population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abiraterone Plus Leuprolide Plus Prednisone', 'description': "Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks."}, {'id': 'OG001', 'title': 'Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone', 'description': 'Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.'}], 'classes': [{'title': 'Testosterone', 'categories': [{'measurements': [{'value': '0.216', 'spread': '0.6707', 'groupId': 'OG000'}, {'value': '0.062', 'spread': '0.0340', 'groupId': 'OG001'}]}]}, {'title': 'DHT', 'categories': [{'measurements': [{'value': '1.340', 'spread': '3.5099', 'groupId': 'OG000'}, {'value': '2.456', 'spread': '6.3901', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1423', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '1.43', 'ciLowerLimit': '0.956', 'ciUpperLimit': '2.145', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.', 'groupDescription': 'Statistical Analysis 1 for testosterone concentration at Week 24', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6639', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '0.82', 'ciLowerLimit': '0.386', 'ciUpperLimit': '1.746', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.', 'groupDescription': 'Statistical Analysis 2 for DHT concentration at Week 24', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Dihydrotestosterone (DHT) is a potent androgenic metabolite of testosterone. Testosterone and DHT concentration was measured in prostate tissues after exposure to study treatments at Week 24.', 'unitOfMeasure': 'Picogram per milligram (pg/mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abiraterone Plus Leuprolide Plus Prednisone', 'description': "Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks."}, {'id': 'OG001', 'title': 'Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone', 'description': 'Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.'}], 'classes': [{'title': 'Androstenedione: Week 12 (n=28,27)', 'categories': [{'measurements': [{'value': '0.082', 'spread': '0.0525', 'groupId': 'OG000'}, {'value': '0.277', 'spread': '0.1729', 'groupId': 'OG001'}]}]}, {'title': 'Androstenedione: Week 24 (n=28,26)', 'categories': [{'measurements': [{'value': '0.090', 'spread': '0.0879', 'groupId': 'OG000'}, {'value': '0.070', 'spread': '0.0403', 'groupId': 'OG001'}]}]}, {'title': 'DHEA: Week 12 (n=28,27)', 'categories': [{'measurements': [{'value': '1.994', 'spread': '5.0266', 'groupId': 'OG000'}, {'value': '29.241', 'spread': '26.9800', 'groupId': 'OG001'}]}]}, {'title': 'DHEA: Week 24 (n=28,26)', 'categories': [{'measurements': [{'value': '3.138', 'spread': '8.6692', 'groupId': 'OG000'}, {'value': '2.170', 'spread': '3.7095', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '0.32', 'ciLowerLimit': '0.239', 'ciUpperLimit': '0.418', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.', 'groupDescription': 'Statistical Analysis 1 for androstenedione concentration at Week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5061', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '1.13', 'ciLowerLimit': '0.828', 'ciUpperLimit': '1.554', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.', 'groupDescription': 'Statistical Analysis 2 for androstenedione concentration at Week 24', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '0.03', 'ciLowerLimit': '0.017', 'ciUpperLimit': '0.050', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.', 'groupDescription': 'Statistical Analysis 3 for DHEA concentration at Week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5767', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '0.79', 'ciLowerLimit': '0.398', 'ciUpperLimit': '1.581', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.', 'groupDescription': 'Statistical Analysis 4 for DHEA concentration at Week 24', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 and 24', 'description': 'Androstenedione is a steroid (a group of polycyclic compounds closely related biochemically to terpenes, for example, cholesterol, numerous hormones), that is produced in the testis, ovary and the adrenal cortex, and depending on the tissue type, androstenedione can serve as a precursor to testosterone, estrone and estradiol. The DHEA is a major steroid produced by the adrenal cortex. It is also produced in small quantities in the testis and the ovary. Androstenedione and DHEA concentration was measured in prostate tissues at Week 12 and 24.', 'unitOfMeasure': 'Picogram per milligram (pg/mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all the participants who were randomly assigned to the study treatment. \'N\' (number of participants analyzed) signifies the participants evaluable for this measure and "n" signifies those participants who were evaluated for this measure at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Serum Levels of Androgens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abiraterone Plus Leuprolide Plus Prednisone', 'description': "Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks."}, {'id': 'OG001', 'title': 'Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone', 'description': 'Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.'}], 'classes': [{'title': 'Testosterone: Week 12 (n=28,28)', 'categories': [{'measurements': [{'value': '1.049', 'spread': '1.0374', 'groupId': 'OG000'}, {'value': '10.014', 'spread': '12.5981', 'groupId': 'OG001'}]}]}, {'title': 'Testosterone: Week 24 (n=25,25)', 'categories': [{'measurements': [{'value': '0.648', 'spread': '0.4975', 'groupId': 'OG000'}, {'value': '3.122', 'spread': '12.6460', 'groupId': 'OG001'}]}]}, {'title': 'DHT: Week 12 (n=28,28)', 'categories': [{'measurements': [{'value': '6.143', 'spread': '8.9868', 'groupId': 'OG000'}, {'value': '5.797', 'spread': '5.9816', 'groupId': 'OG001'}]}]}, {'title': 'DHT: Week 24 (n=26,26)', 'categories': [{'measurements': [{'value': '5.932', 'spread': '9.1599', 'groupId': 'OG000'}, {'value': '6.730', 'spread': '15.7929', 'groupId': 'OG001'}]}]}, {'title': 'Androsterone: Week 12 (n=28,28)', 'categories': [{'measurements': [{'value': '0.619', 'spread': '0.4473', 'groupId': 'OG000'}, {'value': '3.100', 'spread': '5.8891', 'groupId': 'OG001'}]}]}, {'title': 'Androsterone: Week 24 (26,26)', 'categories': [{'measurements': [{'value': '1.752', 'spread': '6.3226', 'groupId': 'OG000'}, {'value': '0.500', 'spread': '0.0000', 'groupId': 'OG001'}]}]}, {'title': 'DHEA: Week 12 (n=28,28)', 'categories': [{'measurements': [{'value': '10.684', 'spread': '27.2814', 'groupId': 'OG000'}, {'value': '180.307', 'spread': '133.6277', 'groupId': 'OG001'}]}]}, {'title': 'DHEA: Week 24 (n=26,26)', 'categories': [{'measurements': [{'value': '20.922', 'spread': '64.2594', 'groupId': 'OG000'}, {'value': '7.617', 'spread': '14.5386', 'groupId': 'OG001'}]}]}, {'title': 'DHEA-Glucuronide: Week 12 (n=29,28)', 'categories': [{'measurements': [{'value': '69.724', 'spread': '184.2399', 'groupId': 'OG000'}, {'value': '583.036', 'spread': '879.7514', 'groupId': 'OG001'}]}]}, {'title': 'DHEA-Glucuronide: Week 24 (n=27,27)', 'categories': [{'measurements': [{'value': '51.675', 'spread': '148.9412', 'groupId': 'OG000'}, {'value': '51.759', 'spread': '95.0666', 'groupId': 'OG001'}]}]}, {'title': 'DHEA-Sulfate: Week 12 (n=28,28)', 'categories': [{'measurements': [{'value': '7156.270', 'spread': '22406.7048', 'groupId': 'OG000'}, {'value': '133338.875', 'spread': '108819.6403', 'groupId': 'OG001'}]}]}, {'title': 'DHEA-Sulfate: Week 24 (n=26,26)', 'categories': [{'measurements': [{'value': '9047.406', 'spread': '27844.7883', 'groupId': 'OG000'}, {'value': '9207.345', 'spread': '30897.5488', 'groupId': 'OG001'}]}]}, {'title': 'Delta-4-Androstenedione:Week 12(n=28,28)', 'categories': [{'measurements': [{'value': '3.315', 'spread': '3.3858', 'groupId': 'OG000'}, {'value': '33.330', 'spread': '26.8110', 'groupId': 'OG001'}]}]}, {'title': 'Delta-4-Androstenedione:Week 24(n=26,26)', 'categories': [{'measurements': [{'value': '5.192', 'spread': '10.8654', 'groupId': 'OG000'}, {'value': '2.831', 'spread': '1.1596', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '0.14', 'ciLowerLimit': '0.097', 'ciUpperLimit': '0.207', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using analysis of covariance (ANCOVA) adjusting for Baseline risk factor and Baseline androgen.', 'groupDescription': 'Statistical Analysis 1 for serum testosterone concentration at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4364', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '0.84', 'ciLowerLimit': '0.571', 'ciUpperLimit': '1.225', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.', 'groupDescription': 'Statistical Analysis 2 for serum testosterone concentration at Week 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1515', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '0.75', 'ciLowerLimit': '0.540', 'ciUpperLimit': '1.044', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.', 'groupDescription': 'Statistical Analysis 3 for serum DHT concentration at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3965', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '0.84', 'ciLowerLimit': '0.589', 'ciUpperLimit': '1.188', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.', 'groupDescription': 'Statistical Analysis 4 for serum DHT concentration at Week 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '0.42', 'ciLowerLimit': '0.290', 'ciUpperLimit': '0.615', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.', 'groupDescription': 'Statistical Analysis 5 for serum Androsterone concentration at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2494', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '1.22', 'ciLowerLimit': '0.916', 'ciUpperLimit': '1.625', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.', 'groupDescription': 'Statistical Analysis 6 for serum androsterone concentration at Week 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '0.04', 'ciLowerLimit': '0.023', 'ciUpperLimit': '0.073', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.', 'groupDescription': 'Statistical Analysis 7 for serum DHEA concentration at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5144', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '1.24', 'ciLowerLimit': '0.717', 'ciUpperLimit': '2.137', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.', 'groupDescription': 'Statistical Analysis 8 for serum DHEA concentration at Week 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '0.10', 'ciLowerLimit': '0.055', 'ciUpperLimit': '0.189', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.', 'groupDescription': 'Statistical Analysis 9 for serum DHEA-glucuronide concentration at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1329', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '0.55', 'ciLowerLimit': '0.286', 'ciUpperLimit': '1.060', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.', 'groupDescription': 'Statistical Analysis 10 for serum DHEA-glucuronide concentration at Week 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '0.01', 'ciLowerLimit': '0.008', 'ciUpperLimit': '0.028', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.', 'groupDescription': 'Statistical Analysis 11 for serum DHEA-sulfate concentration at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7061', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '1.20', 'ciLowerLimit': '0.530', 'ciUpperLimit': '2.730', 'groupDescription': 'Statistical Analysis 12 for serum DHEA-sulfate concentration at Week 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '0.42', 'ciLowerLimit': '0.290', 'ciUpperLimit': '0.615', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.', 'groupDescription': 'Statistical Analysis 13 for serum delta-4-androstenedione concentration at Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2673', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '1.22', 'ciLowerLimit': '0.916', 'ciUpperLimit': '1.625', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.', 'groupDescription': 'Statistical Analysis 14 for serum delta-4-androstenedione concentration at Week 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 and 24', 'description': 'Serum concentrations of testosterone, DHT, androsterone, DHEA, DHEA-Sulfate, DHEA-Glucuronide and delta-4-androstenedione were measured at Weeks 12 and 24.', 'unitOfMeasure': 'Nanogram per deciliter (ng/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all the participants who were randomly assigned to the study treatment. \'N\' (number of participants analyzed) signifies the participants evaluable for this measure and "n" signifies those participants who were evaluated for this measure at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Prostate-specific Antigen (PSA) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abiraterone Plus Leuprolide Plus Prednisone', 'description': "Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks."}, {'id': 'OG001', 'title': 'Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone', 'description': 'Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '86.7', 'spread': '0.0637', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.3788', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000'}, {'value': '82.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative risk', 'ciPctValue': '90', 'paramValue': '25.533', 'ciLowerLimit': '4.989', 'ciUpperLimit': '130.680', 'groupDescription': 'Statistical Analysis 1 for PSA response at Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2319', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative risk', 'ciPctValue': '90', 'paramValue': '1.131', 'ciLowerLimit': '0.956', 'ciUpperLimit': '1.337', 'groupDescription': 'Statistical Analysis 2 for PSA response at Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12 and 24', 'description': 'The PSA response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criterion which is, percentage of participants with PSA less than or equal to 0.2 nanogram/milliliter at Weeks 12 and 24 after androgen deprivation.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all the participants who were randomly assigned to the study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pathologic Complete Response (CR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abiraterone Plus Leuprolide Plus Prednisone', 'description': "Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks."}, {'id': 'OG001', 'title': 'Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone', 'description': 'Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '0.0637', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.3788', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3427', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative risk', 'ciPctValue': '90', 'paramValue': '2.744', 'ciLowerLimit': '1.018', 'ciUpperLimit': '5.015', 'groupDescription': 'Statistical Analysis 1 for CR at Week 24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Complete response is defined as a disappearance of all target lesions and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criterion.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Tumor Expression of Androgen Receptor (AR) Regulated Genes at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abiraterone Plus Leuprolide Plus Prednisone', 'description': "Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks."}, {'id': 'OG001', 'title': 'Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone', 'description': 'Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.'}], 'timeFrame': 'Week 24', 'description': 'Tumor expression of AR regulated genes determined by real-time polymerase chain reaction (RT PCR). PCR is an in vitro method for producing large amounts of specific deoxyribonucleic acid (DNA) or ribonucleic acid fragments of defined length and sequence from small amounts of short oligonucleotide flanking sequences (primers). RT PCR is a method used for detecting the amplified DNA products from the PCR as they accumulate instead of at the end of the reaction.', 'reportingStatus': 'POSTED', 'populationDescription': 'Resullts were not reported due to insufficient data in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Correlation Between Molecular and Protein Expression With Intracellular Androgen Levels and Pathologic Response to Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abiraterone Plus Leuprolide Plus Prednisone', 'description': "Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks."}, {'id': 'OG001', 'title': 'Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone', 'description': 'Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.'}], 'timeFrame': 'Week 24', 'description': 'Molecular and protein expression was correlated with intracellular androgen levels and pathologic response to study treatment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Resullts were not reported due to insufficient data in this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Dihydrotestosterone (DHT) Concentration in Prostate Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abiraterone Plus Leuprolide Plus Prednisone', 'description': "Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks."}, {'id': 'OG001', 'title': 'Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone', 'description': 'Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.311', 'spread': '21.6213', 'groupId': 'OG000'}, {'value': '2.170', 'spread': '3.4589', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean ratio', 'ciPctValue': '90', 'paramValue': '0.17', 'ciLowerLimit': '0.098', 'ciUpperLimit': '0.289', 'pValueComment': 'Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.', 'groupDescription': 'Statistical Analysis 2 for DHT concentration at Week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The DHT is a potent androgenic metabolite of testosterone and the concentration of DHT was measured in prostate tissues after exposure to study treatments at Week 12.', 'unitOfMeasure': 'Picogram per milligram (pg/mg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat (ITT) population included all the participants who were randomly assigned to the study treatment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Abiraterone Plus Leuprolide Plus Prednisone', 'description': "Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks."}, {'id': 'FG001', 'title': 'Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone', 'description': 'Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Abiraterone Plus Leuprolide Plus Prednisone', 'description': "Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks."}, {'id': 'BG001', 'title': 'Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone', 'description': 'Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'spread': '6.67', 'groupId': 'BG000'}, {'value': '56.9', 'spread': '5.30', 'groupId': 'BG001'}, {'value': '59.0', 'spread': '6.35', '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': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-06', 'studyFirstSubmitDate': '2009-06-17', 'resultsFirstSubmitDate': '2013-03-06', 'studyFirstSubmitQcDate': '2009-06-18', 'lastUpdatePostDateStruct': {'date': '2013-04-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-06', 'studyFirstPostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Testosterone Concentration in Prostate Tissue', 'timeFrame': 'Week 12', 'description': 'Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12.'}, {'measure': 'Dihydrotestosterone (DHT) Concentration in Prostate Tissue', 'timeFrame': 'Week 12', 'description': 'The DHT is a potent androgenic metabolite of testosterone and the concentration of DHT was measured in prostate tissues after exposure to study treatments at Week 12.'}], 'secondaryOutcomes': [{'measure': 'Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue', 'timeFrame': 'Week 24', 'description': 'Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Dihydrotestosterone (DHT) is a potent androgenic metabolite of testosterone. Testosterone and DHT concentration was measured in prostate tissues after exposure to study treatments at Week 24.'}, {'measure': 'Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue', 'timeFrame': 'Week 12 and 24', 'description': 'Androstenedione is a steroid (a group of polycyclic compounds closely related biochemically to terpenes, for example, cholesterol, numerous hormones), that is produced in the testis, ovary and the adrenal cortex, and depending on the tissue type, androstenedione can serve as a precursor to testosterone, estrone and estradiol. The DHEA is a major steroid produced by the adrenal cortex. It is also produced in small quantities in the testis and the ovary. Androstenedione and DHEA concentration was measured in prostate tissues at Week 12 and 24.'}, {'measure': 'Serum Levels of Androgens', 'timeFrame': 'Week 12 and 24', 'description': 'Serum concentrations of testosterone, DHT, androsterone, DHEA, DHEA-Sulfate, DHEA-Glucuronide and delta-4-androstenedione were measured at Weeks 12 and 24.'}, {'measure': 'Percentage of Participants With Prostate-specific Antigen (PSA) Response', 'timeFrame': 'Weeks 12 and 24', 'description': 'The PSA response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criterion which is, percentage of participants with PSA less than or equal to 0.2 nanogram/milliliter at Weeks 12 and 24 after androgen deprivation.'}, {'measure': 'Percentage of Participants With Pathologic Complete Response (CR)', 'timeFrame': 'Week 24', 'description': 'Complete response is defined as a disappearance of all target lesions and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criterion.'}, {'measure': 'Number of Participants With Tumor Expression of Androgen Receptor (AR) Regulated Genes at Week 24', 'timeFrame': 'Week 24', 'description': 'Tumor expression of AR regulated genes determined by real-time polymerase chain reaction (RT PCR). PCR is an in vitro method for producing large amounts of specific deoxyribonucleic acid (DNA) or ribonucleic acid fragments of defined length and sequence from small amounts of short oligonucleotide flanking sequences (primers). RT PCR is a method used for detecting the amplified DNA products from the PCR as they accumulate instead of at the end of the reaction.'}, {'measure': 'Correlation Between Molecular and Protein Expression With Intracellular Androgen Levels and Pathologic Response to Study Treatment', 'timeFrame': 'Week 24', 'description': 'Molecular and protein expression was correlated with intracellular androgen levels and pathologic response to study treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate cancer', 'Abiraterone acetate', 'Leuprolide acetate', 'Prednisone', 'CB7630', 'Testosterone'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety and efficacy of abiraterone acetate plus leuprolide acetate and prednisone, versus leuprolide acetate alone in male participants with prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors) who are suitable candidates for prostatectomy (surgery to remove all or part of the prostate gland).', 'detailedDescription': "This is an open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), and multi-center (conducted in more than one center) study of abiraterone in male participants with prostate cancer. The duration of study will be approximately 24-32 weeks per participant. The study consists of 4 parts: Screening (that is, 30 days before study commences on Day 1); Treatment (abiraterone acetate 1000 milligram per day or leuprolide acetate as 22.5 milligram intramuscular injection \\[injection of a substance into a muscle\\] or prednisone 5 mg once daily); Prostatectomy (Week 24); and Follow-up ( 4-8 weeks after prostatectomy). Participants will receive either abiraterone, leuprolide and prednisone for 24 weeks (that is, Group 1) or leuprolide once every 12 weeks up to Week 24 then abiraterone and prednisone from Week 13 to 24 (that is, Group 2). All the eligible participants will be randomly assigned to 1 of the 2 treatment groups. Efficacy will be evaluated primarily through the concentrations of testosterone and dihydrotestosterone from prostate tissues at Week 12. Participants' safety will be monitored throughout the study."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* At least three core biopsies positive for prostate cancer (a minimum of 6 core biopsies must be obtained at baseline). A prostate biopsy within 6 months from Screening is allowed for entry requirements\n* At least one of the following features: prostate specific antigen (PSA) greater than (\\>) 10 nanogram per milliliter (ng/ml); PSA velocity \\>2 ng/ml per /year (defined as a rise in PSA of \\>2 ng/ml in the preceding 12 month period); Gleason score greater than or equal to (\\>=) 7 (4+3); Gleason score 6 if either PSA \\>=10 ng/ml or PSA velocity \\>=2 ng/ml/year\n* Serum testosterone \\>200 nanogram/deciliter\n* Participant and urologist must agree that participant is suitable for prostatectomy\n\nExclusion Criteria:\n\n* Serious or uncontrolled co-existent, non-malignant disease, including active and uncontrolled infection\n* Abnormal liver function consisting of any of the following: serum bilirubin \\>= 1.5 \\* upper limit of normal (ULN); aspartate aminotransferase or alanine aminotransferase \\>=2.5 \\* ULN\n* Uncontrolled hypertension within the Screening period (systolic blood pressure \\>= 160 millimeter of mercury \\[mmHg\\] or diastolic BP \\>= 95 mmHg)\n* Requirement for corticosteroids greater than the equivalent of 5 milligram of prednisone daily\n* Participants with active or symptomatic viral hepatitis or chronic liver disease or clinically significant heart disease or as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \\< 50 percent at Baseline or history of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug or history of pituitary or adrenal dysfunction'}, 'identificationModule': {'nctId': 'NCT00924469', 'briefTitle': 'A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Phase 2 Open-Label, Randomized, Multi-center Study of Neoadjuvant Abiraterone Acetate (CB7630) Plus Leuprolide Acetate and Prednisone Versus Leuprolide Acetate Alone in Men With Localized High Risk Prostate Cancer', 'orgStudyIdInfo': {'id': 'CR016936'}, 'secondaryIdInfos': [{'id': 'COU-AA-201', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abiraterone plus leuprolide plus prednisone', 'description': "Abiraterone acetate tablets will be administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate will be administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone tablets will be administered orally as 5 mg once daily for 24 weeks.", 'interventionNames': ['Drug: Abiraterone', 'Drug: Leuprolide', 'Drug: Prednisone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Leuprolide then abiraterone plus leuprolide plus prednisone', 'description': 'Leuprolide acetate will be administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day with prednisone tablets administered orally as 5 mg once daily.', 'interventionNames': ['Drug: Abiraterone', 'Drug: Leuprolide', 'Drug: Prednisone']}], 'interventions': [{'name': 'Abiraterone', 'type': 'DRUG', 'otherNames': ['CB7630'], 'description': 'Abiraterone acetate tablets will be administered orally at a total dose of 1000 milligram (mg) per day at least 1 hour before a meal or 2 hours after a meal for 24 weeks in Group 1 and from Week 13 to Week 24 for Group 2.', 'armGroupLabels': ['Abiraterone plus leuprolide plus prednisone', 'Leuprolide then abiraterone plus leuprolide plus prednisone']}, {'name': 'Leuprolide', 'type': 'DRUG', 'description': "Leuprolide acetate will be administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks in Group 1 and Group 2.", 'armGroupLabels': ['Abiraterone plus leuprolide plus prednisone', 'Leuprolide then abiraterone plus leuprolide plus prednisone']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Prednisone tablets will be administered orally as 5 mg once daily for 24 weeks in Group 1 and from Week 13 to Week 24 for Group 2.', 'armGroupLabels': ['Abiraterone plus leuprolide plus prednisone', 'Leuprolide then abiraterone plus leuprolide plus prednisone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Wenatchee', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.42346, 'lon': -120.31035}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}