Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-01-05 @ 6:13 PM
Study NCT ID:
NCT02903368
Status:
COMPLETED
Last Update Posted:
2025-06-13
First Post:
2016-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy
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': 'C572045', 'term': 'apalutamide'}, {'id': 'D016729', 'term': 'Leuprolide'}, {'id': 'C493311', 'term': 'luprolide acetate gel depot'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D000069501', 'term': 'Abiraterone Acetate'}], 'ancestors': [{'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'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mtaplin@partners.org', 'phone': '617-582-7221', 'title': 'Mary-Ellen Taplin, MD', 'organization': 'Dana-Farber Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Part 1: Adverse events (AE) and Serious AEs (SAE) during neoadjuvant therapy collected on Day 1 of each cycle (+/-2 days) from the first dose of the study drugs until 30 days after discontinuation of the neoadjuvant therapy, up to 7 months from treatment initiation. Part 2: AE and SAE during adjuvant therapy collected from the date informed consent is signed (for Part 2) until 30 days after discontinuation from adjuvant treatment, up to 13 months from adjuvant treatment initiation.', 'description': 'Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1A: AAPL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 59, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Arm 1B: APL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAPL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 59, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Arm 2A: AAPL Adjuvant Therapy (Part 2)', 'description': 'Eligible participants will be randomized to receive adjuvant AAPL post surgery: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months\n\nOf the 42 patients randomized to Arm 2A, only 37 patients received the AAPL treatment; 5 patients declined protocol treatment after part-2 randomization. Therefore, toxicities for Arm 2A were reported among the 37 patients who actually received AAPL treatment.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 30, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Arm 2B: Observation (Part 2)', 'description': 'Eligible participants will be randomized to the observation arm post surgery.\n\nOf the 40 patients randomized to Arm 2B (observation), 38 remained on observation and 2 received non-protocol therapy. Therefore, the AE analysis for Arm 2B included the 38 patients on observation, excluding 2 patient receiving non-protocol therapy.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 28, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bladder spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blood and lymphatic system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cholesterol high', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cognitive disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rectal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Renal and urinary disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Voice alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Combined pCR or MRD Rate [Part 1]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1A: AAPL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months'}, {'id': 'OG001', 'title': 'Arm 1B: APL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAPL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 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Pathological Complete Response (pCR) is defined as the absence of morphologically identifiable carcinoma in the RP specimen. MRD will be defined as residual tumor in the RP specimen measuring ≤ 5 mm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '114 patients (55 in AAPL Arm and 59 in APL Arm) had RP pathologic assessment, excluding the four who withdrew prior to RP.'}, {'type': 'PRIMARY', 'title': 'Biochemical Progression Free Survival (bPFS) Rate at 3 Years Post RP [Part 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2A: AAPL Adjuvant Therapy (Part 2)', 'description': 'Eligible participants will be randomized to receive adjuvant AAPL post surgery: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months'}, {'id': 'OG001', 'title': 'Arm 2B: Observation (Part 2)', 'description': 'Eligible participants will be randomized to the observation arm post surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '89'}, {'value': '72', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '82'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 3 years post RP', 'description': '3-year bPFS rate is defined as the probability of biochemical progression free and survival at 3 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 3-year mark are censored at date last disease evaluation.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analysis was the intent-to-treat approach, including all patients who have been randomized into Part 2 of the study.'}, {'type': 'SECONDARY', 'title': 'Rate of pCR at RP (Part 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1A: AAPL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months'}, {'id': 'OG001', 'title': 'Arm 1B: APL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAPL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.', 'description': 'Pathological Complete Response (pCR) is defined as the absence of morphologically identifiable carcinoma in the RP specimen at radical prostatectomy (RP).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '114 patients (55 in AAPL Arm and 59 in APL Arm) had RP pathologic assessment, excluding the four who withdrew prior to RP.'}, {'type': 'SECONDARY', 'title': 'Median of Residual Cancer Burden (RCB) at RP (Part 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1A: AAPL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months'}, {'id': 'OG001', 'title': 'Arm 1B: APL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAPL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.023', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7.8'}, {'value': '0.075', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.', 'description': 'RCB was calculated as "tumor volume (cm\\^3) X % cellularity". RCB was analyzed as a continuous score (with median and range) instead of a categorical variable based on the percentile cutoff point, at the time of radical prostatectomy (RP).', 'unitOfMeasure': '(cm^3) * %', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '114 patients (55 in AAPL Arm and 59 in APL Arm) had RP pathologic assessment, excluding the four who withdrew prior to RP.'}, {'type': 'SECONDARY', 'title': 'Frequency of Presenting Cribriform at RP (Part 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1A: AAPL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months'}, {'id': 'OG001', 'title': 'Arm 1B: APL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAPL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.', 'description': 'Presence or cribriform was evaluated by central pathology review of specimens at radical prostatectomy (RP).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '114 patients (55 in AAPL Arm and 59 in APL Arm) had RP pathologic assessment, excluding the four who withdrew prior to RP.'}, {'type': 'SECONDARY', 'title': 'Frequency of Presenting Intraductal Carcinoma at RP (Part 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1A: AAPL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months'}, {'id': 'OG001', 'title': 'Arm 1B: APL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAPL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.', 'description': 'Intraductal carcinoma was evaluated by central pathology review of specimens at Radical Prostatectomy (RP).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '114 patients (55 in AAPL Arm and 59 in APL Arm) had RP pathologic assessment, excluding the four who withdrew prior to RP.'}, {'type': 'SECONDARY', 'title': 'Frequency of Positive Surgical Margins at RP (Part 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1A: AAPL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months'}, {'id': 'OG001', 'title': 'Arm 1B: APL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAPL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.', 'description': 'Pathologic specimens were centrally reviewed and counted for positive surgical margins at the time of Radical Prostatectomy (RP).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '114 patients (55 in AAPL Arm and 59 in APL Arm) had RP pathologic assessment, excluding the four who withdrew prior to RP.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Nadir PSA < 0.2 ng/mL Prior to RP (Part 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1A: AAPL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months'}, {'id': 'OG001', 'title': 'Arm 1B: APL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAPL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed on day 1 of each cycle (1 cycle=28 +/- 2 days), up to 6 months from the initiation of neoadjuvant therapy.', 'description': 'Prostate specific antigen (PSA) was measured on day 1 of each cycle during the neoadjuvant therapy. PSA nadir was defined as the lowest PSA value prior to Radical Prostatectomy (RP). Number and percent of participants with nadir PSA \\< 0.2 ng/mL were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PSA nadir was collected in 115 patients (56 in AAPL Arm and 59 in APL Arm).'}, {'type': 'SECONDARY', 'title': 'Frequency of Presenting Intra-operative Complications Following RP (Part 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1A: AAPL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months'}, {'id': 'OG001', 'title': 'Arm 1B: APL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAPL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed post-RP, at 6 months from the initiation of neoadjuvant therapy.', 'description': 'Intra-operative complications were collected via questionnaire following Radical Prostatectomy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Assessed in 114 patients (55 in AAPL Arm and 59 in APL Arm) who received RP, excluding the four who withdrew prior to RP.'}, {'type': 'SECONDARY', 'title': 'Biochemical Progression Free Survival (bPFS) Rate at 2 Years Post RP [Part 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2A: AAPL Adjuvant Therapy (Part 2)', 'description': 'Eligible participants will be randomized to receive adjuvant AAPL post surgery: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months'}, {'id': 'OG001', 'title': 'Arm 2B: Observation (Part 2)', 'description': 'Eligible participants will be randomized to the observation arm post surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '96'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '88'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 2 years post RP', 'description': '2-year bPFS rate is defined as the probability of biochemical progression free and survival at 2 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 2-year mark are censored at date of last disease evaluation.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Biochemical Progression Free Survival (bPFS) Rate at 4 Years Post RP [Part 2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2A: AAPL Adjuvant Therapy (Part 2)', 'description': 'Eligible participants will be randomized to receive adjuvant AAPL post surgery: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months'}, {'id': 'OG001', 'title': 'Arm 2B: Observation (Part 2)', 'description': 'Eligible participants will be randomized to the observation arm post surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '78'}, {'value': '61', 'groupId': 'OG001', 'lowerLimit': '47', 'upperLimit': '73'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 4 years post RP', 'description': '4-year bPFS rate is defined as the probability of biochemical progression free and survival at 4 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 4-year mark are censored at date of last disease evaluation.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Freedom From Further Anti-cancer Therapy at 2-years Post RP (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2A: AAPL Adjuvant Therapy (Part 2)', 'description': 'Eligible participants will be randomized to receive adjuvant AAPL post surgery: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months'}, {'id': 'OG001', 'title': 'Arm 2B: Observation (Part 2)', 'description': 'Eligible participants will be randomized to the observation arm post surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '96'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '88'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 2-years post RP', 'description': 'Defined as the probability of freedom from further anti-cancer therapy at 2-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 2-year mark are censored at date of last follow-up.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Freedom From Further Anti-cancer Therapy at 3-years Post RP (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2A: AAPL Adjuvant Therapy (Part 2)', 'description': 'Eligible participants will be randomized to receive adjuvant AAPL post surgery: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months'}, {'id': 'OG001', 'title': 'Arm 2B: Observation (Part 2)', 'description': 'Eligible participants will be randomized to the observation arm post surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '91'}, {'value': '72', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '82'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 3 years post RP', 'description': 'Defined as the probability of freedom from further anti-cancer therapy at 3-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 3-year mark are censored at date of last follow-up.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Freedom From Further Anti-cancer Therapy at 4-years Post RP (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2A: AAPL Adjuvant Therapy (Part 2)', 'description': 'Eligible participants will be randomized to receive adjuvant AAPL post surgery: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months'}, {'id': 'OG001', 'title': 'Arm 2B: Observation (Part 2)', 'description': 'Eligible participants will be randomized to the observation arm post surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '87'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '53', 'upperLimit': '78'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 4-years post RP', 'description': 'Defined as the probability of freedom from further anti-cancer therapy at 4-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 4-year mark are censored at date of last follow-up.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 6-months Post-RP (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2A: AAPL Adjuvant Therapy (Part 2)', 'description': 'Eligible participants will be randomized to receive adjuvant AAPL post surgery: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months'}, {'id': 'OG001', 'title': 'Arm 2B: Observation (Part 2)', 'description': 'Eligible participants will be randomized to the observation arm post surgery'}], 'classes': [{'title': 'Urinary Irritative', 'categories': [{'measurements': [{'value': '90', 'spread': '11', 'groupId': 'OG000'}, {'value': '92', 'spread': '8', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Incontinence', 'categories': [{'measurements': [{'value': '63', 'spread': '24', 'groupId': 'OG000'}, {'value': '72', 'spread': '23', 'groupId': 'OG001'}]}]}, {'title': 'Bowel', 'categories': [{'measurements': [{'value': '95', 'spread': '11', 'groupId': 'OG000'}, {'value': '96', 'spread': '7', 'groupId': 'OG001'}]}]}, {'title': 'Sexual', 'categories': [{'measurements': [{'value': '17', 'spread': '19', 'groupId': 'OG000'}, {'value': '14', 'spread': '14', 'groupId': 'OG001'}]}]}, {'title': 'Hormonal', 'categories': [{'measurements': [{'value': '68', 'spread': '20', 'groupId': 'OG000'}, {'value': '83', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 6-months post-RP', 'description': 'The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL.', 'unitOfMeasure': 'Score on 0-100', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '32 subjects receiving Arm 2A and 34 receiving Arm 2B completed EPIC-26 QOL questionnaires at 6 months post RP.'}, {'type': 'SECONDARY', 'title': 'Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 12-months Post-RP (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2A: AAPL Adjuvant Therapy (Part 2)', 'description': 'Eligible participants will be randomized to receive adjuvant AAPL post surgery: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months'}, {'id': 'OG001', 'title': 'Arm 2B: Observation (Part 2)', 'description': 'Eligible participants will be randomized to the observation arm post surgery'}], 'classes': [{'title': 'Urinary Irritative', 'categories': [{'measurements': [{'value': '91', 'spread': '11', 'groupId': 'OG000'}, {'value': '91', 'spread': '10', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Incontinence', 'categories': [{'measurements': [{'value': '75', 'spread': '24', 'groupId': 'OG000'}, {'value': '74', 'spread': '25', 'groupId': 'OG001'}]}]}, {'title': 'Bowel', 'categories': [{'measurements': [{'value': '95', 'spread': '12', 'groupId': 'OG000'}, {'value': '94', 'spread': '12', 'groupId': 'OG001'}]}]}, {'title': 'Sexual', 'categories': [{'measurements': [{'value': '16', 'spread': '18', 'groupId': 'OG000'}, {'value': '26', 'spread': '26', 'groupId': 'OG001'}]}]}, {'title': 'Hormonal', 'categories': [{'measurements': [{'value': '68', 'spread': '22', 'groupId': 'OG000'}, {'value': '86', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 12-months post-RP', 'description': 'The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL.', 'unitOfMeasure': 'score on 0-100 scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '32 subjects receiving Arm 2A and 39 receiving Arm 2B completed EPIC-26 QOL questionnaires at 12 months post RP.'}, {'type': 'SECONDARY', 'title': 'Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 24-months Post-RP (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2A: AAPL Adjuvant Therapy (Part 2)', 'description': 'Eligible participants will be randomized to receive adjuvant AAPL post surgery: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months'}, {'id': 'OG001', 'title': 'Arm 2B: Observation (Part 2)', 'description': 'Eligible participants will be randomized to the observation arm post surgery'}], 'classes': [{'title': 'Urinary Irritative', 'categories': [{'measurements': [{'value': '92', 'spread': '12', 'groupId': 'OG000'}, {'value': '93', 'spread': '9', 'groupId': 'OG001'}]}]}, {'title': 'Urinary Incontinence', 'categories': [{'measurements': [{'value': '75', 'spread': '22', 'groupId': 'OG000'}, {'value': '76', 'spread': '30', 'groupId': 'OG001'}]}]}, {'title': 'Bowel', 'categories': [{'measurements': [{'value': '95', 'spread': '12', 'groupId': 'OG000'}, {'value': '97', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'Sexual', 'categories': [{'measurements': [{'value': '31', 'spread': '31', 'groupId': 'OG000'}, {'value': '26', 'spread': '30', 'groupId': 'OG001'}]}]}, {'title': 'Hormonal', 'categories': [{'measurements': [{'value': '88', 'spread': '20', 'groupId': 'OG000'}, {'value': '90', 'spread': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 24-months post-RP', 'description': 'The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL.', 'unitOfMeasure': 'score on 0-100 scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '14 subjects receiving Arm 2A and 12 receiving Arm 2B completed EPIC-26 QOL questionnaires at 24 months post RP. The QOL questionnaire completion rate was low at the 24-month visit. Due to the Covid19 pandemic, many follow-up visits were conducted virtually. These questionnaires were done when possible and the patients were back in the clinic.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1A: AAPL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible participants will be randomized to receive:\n\nAAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months.'}, {'id': 'FG001', 'title': 'Arm 1B: APL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAPL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months'}, {'id': 'FG002', 'title': 'Arm 2A: AAPL Adjuvant Therapy (Part 2)', 'description': 'Eligible participants will be randomized to receive adjuvant AAPL post surgery: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months'}, {'id': 'FG003', 'title': 'Arm 2B: Observation (Part 2)', 'description': 'Eligible participants will be randomized to the observation arm post surgery'}], 'periods': [{'title': 'Part 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Part 2', 'milestones': [{'type': 'STARTED', 'comment': 'Only 82 patients underwent part 2 randomization; the remaining 36 patients did not participate in part 2 randomization.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject withdrew after 6 cycles of protocol therapy.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject withdrew after part-2 randomization and remained on observation.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject withdrew after part-2 randomization and received non-protocol therapy.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This is a 2-part study:\n\nIn part 1, patients will be randomized in 1:1 ratio to receive 6 months of AAPL (Arm 1A) versus 6 months of APL (Arm 1B) followed by RP, stratified by risk factor.\n\nIn part 2 (post-RP), patients will be randomized in 1:1 ratio to receive an additional 12 months of AAPL (Arm 2A) or observation (Arm 2B) stratified by type of neoadjuvant therapy and pathological T-stage after RP but before cycle 7 day 1 following neoadjuvant therapy.', 'preAssignmentDetails': 'The part 2 of the study is still in progression and the final data has not been collected'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1A: AAPL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months'}, {'id': 'BG001', 'title': 'Arm 1B: APL Neoadjuvant Therapy (Part 1)', 'description': 'Eligible Participants will be randomized to receive:\n\nAPL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '72'}, {'value': '58', 'groupId': 'BG001', 'lowerLimit': '46', 'upperLimit': '72'}, {'value': '61', 'groupId': 'BG002', 'lowerLimit': '46', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'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': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-03', 'size': 2321897, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-29T00:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2016-08-24', 'resultsFirstSubmitDate': '2021-06-02', 'studyFirstSubmitQcDate': '2016-09-12', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-01', 'studyFirstPostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined pCR or MRD Rate [Part 1]', 'timeFrame': 'Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.', 'description': 'Pathological response, defined as achieving either pCR or MRD at radical prostatectomy (RP). Pathological Complete Response (pCR) is defined as the absence of morphologically identifiable carcinoma in the RP specimen. MRD will be defined as residual tumor in the RP specimen measuring ≤ 5 mm.'}, {'measure': 'Biochemical Progression Free Survival (bPFS) Rate at 3 Years Post RP [Part 2]', 'timeFrame': 'At 3 years post RP', 'description': '3-year bPFS rate is defined as the probability of biochemical progression free and survival at 3 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 3-year mark are censored at date last disease evaluation.'}], 'secondaryOutcomes': [{'measure': 'Rate of pCR at RP (Part 1)', 'timeFrame': 'Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.', 'description': 'Pathological Complete Response (pCR) is defined as the absence of morphologically identifiable carcinoma in the RP specimen at radical prostatectomy (RP).'}, {'measure': 'Median of Residual Cancer Burden (RCB) at RP (Part 1)', 'timeFrame': 'Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.', 'description': 'RCB was calculated as "tumor volume (cm\\^3) X % cellularity". RCB was analyzed as a continuous score (with median and range) instead of a categorical variable based on the percentile cutoff point, at the time of radical prostatectomy (RP).'}, {'measure': 'Frequency of Presenting Cribriform at RP (Part 1)', 'timeFrame': 'Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.', 'description': 'Presence or cribriform was evaluated by central pathology review of specimens at radical prostatectomy (RP).'}, {'measure': 'Frequency of Presenting Intraductal Carcinoma at RP (Part 1)', 'timeFrame': 'Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.', 'description': 'Intraductal carcinoma was evaluated by central pathology review of specimens at Radical Prostatectomy (RP).'}, {'measure': 'Frequency of Positive Surgical Margins at RP (Part 1)', 'timeFrame': 'Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.', 'description': 'Pathologic specimens were centrally reviewed and counted for positive surgical margins at the time of Radical Prostatectomy (RP).'}, {'measure': 'Percent of Participants With Nadir PSA < 0.2 ng/mL Prior to RP (Part 1)', 'timeFrame': 'Assessed on day 1 of each cycle (1 cycle=28 +/- 2 days), up to 6 months from the initiation of neoadjuvant therapy.', 'description': 'Prostate specific antigen (PSA) was measured on day 1 of each cycle during the neoadjuvant therapy. PSA nadir was defined as the lowest PSA value prior to Radical Prostatectomy (RP). Number and percent of participants with nadir PSA \\< 0.2 ng/mL were reported.'}, {'measure': 'Frequency of Presenting Intra-operative Complications Following RP (Part 1)', 'timeFrame': 'Assessed post-RP, at 6 months from the initiation of neoadjuvant therapy.', 'description': 'Intra-operative complications were collected via questionnaire following Radical Prostatectomy.'}, {'measure': 'Biochemical Progression Free Survival (bPFS) Rate at 2 Years Post RP [Part 2]', 'timeFrame': 'At 2 years post RP', 'description': '2-year bPFS rate is defined as the probability of biochemical progression free and survival at 2 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 2-year mark are censored at date of last disease evaluation.'}, {'measure': 'Biochemical Progression Free Survival (bPFS) Rate at 4 Years Post RP [Part 2]', 'timeFrame': 'At 4 years post RP', 'description': '4-year bPFS rate is defined as the probability of biochemical progression free and survival at 4 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 4-year mark are censored at date of last disease evaluation.'}, {'measure': 'Rate of Freedom From Further Anti-cancer Therapy at 2-years Post RP (Part 2)', 'timeFrame': 'At 2-years post RP', 'description': 'Defined as the probability of freedom from further anti-cancer therapy at 2-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 2-year mark are censored at date of last follow-up.'}, {'measure': 'Rate of Freedom From Further Anti-cancer Therapy at 3-years Post RP (Part 2)', 'timeFrame': 'At 3 years post RP', 'description': 'Defined as the probability of freedom from further anti-cancer therapy at 3-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 3-year mark are censored at date of last follow-up.'}, {'measure': 'Rate of Freedom From Further Anti-cancer Therapy at 4-years Post RP (Part 2)', 'timeFrame': 'At 4-years post RP', 'description': 'Defined as the probability of freedom from further anti-cancer therapy at 4-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 4-year mark are censored at date of last follow-up.'}, {'measure': 'Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 6-months Post-RP (Part 2)', 'timeFrame': 'At 6-months post-RP', 'description': 'The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL.'}, {'measure': 'Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 12-months Post-RP (Part 2)', 'timeFrame': 'At 12-months post-RP', 'description': 'The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL.'}, {'measure': 'Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 24-months Post-RP (Part 2)', 'timeFrame': 'At 24-months post-RP', 'description': 'The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['abiraterone acetate', 'apalutamide', 'leuprolide', 'prednisone', 'neoadjuvant therapy'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '38161319', 'type': 'DERIVED', 'citation': 'McKay RR, Xie W, Yang X, Acosta A, Rathkopf D, Laudone VP, Bubley GJ, Einstein DJ, Chang P, Wagner AA, Kane CJ, Preston MA, Kilbridge K, Chang SL, Choudhury AD, Pomerantz MM, Trinh QD, Kibel AS, Taplin ME. Postradical prostatectomy prostate-specific antigen outcomes after 6 versus 18 months of perioperative androgen-deprivation therapy in men with localized, unfavorable intermediate-risk or high-risk prostate cancer: Results of part 2 of a randomized phase 2 trial. Cancer. 2024 May 1;130(9):1629-1641. doi: 10.1002/cncr.35170. Epub 2024 Jan 1.'}, {'pmid': '33683939', 'type': 'DERIVED', 'citation': 'McKay RR, Xie W, Ye H, Fennessy FM, Zhang Z, Lis R, Calagua C, Rathkopf D, Laudone VP, Bubley GJ, Einstein DJ, Chang PK, Wagner AA, Parsons JK, Preston MA, Kilbridge K, Chang SL, Choudhury AD, Pomerantz MM, Trinh QD, Kibel AS, Taplin ME. Results of a Randomized Phase II Trial of Intense Androgen Deprivation Therapy prior to Radical Prostatectomy in Men with High-Risk Localized Prostate Cancer. J Urol. 2021 Jul;206(1):80-87. doi: 10.1097/JU.0000000000001702. Epub 2021 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'This multicenter randomized phase II trial investigates the impact of intense androgen deprivation on radical prostatectomy (RP) pathologic response and radiographic and tissue biomarkers in localized prostate cancer (NCT02903368).', 'detailedDescription': 'This is a multicenter, phase II, prospective, randomized trial designed to investigate the efficacy of neoadjuvant and adjuvant abiraterone acetate + apalutamide for men with intermediate-high risk prostate cancer who are candidates for RP.\n\nThe study includes two parts. In part 1, patients will be randomized in 1:1 ratio to receive 6 months of abiraterone acetate, apalutamide, leuprolide and prednisone (Arm 1A) versus 6 months of abiraterone acetate, leuprolide and prednisone (Arm 1B) followed by RP, stratified by risk factor (intermediate versus high-risk). High-risk factors will be defined as a Gleason score ≥ 8, PSA \\> 20 ng/dL, or T3 disease on MRI.\n\nIn part 2 (post-RP), patients will be randomized in 1:1 ratio to receive an additional 12 months of abiraterone acetate, apalutamide, leuprolide and prednisone (Arm 2A) or observation (Arm 2B) stratified by type of neoadjuvant therapy and pathological T-stage (\\< pT3 versus ≥ pT3) after RP but before cycle 7 day 1 following neoadjuvant therapy. There will be an early stopping rule for Part 2 should a high rate of patients refuse to participate or drop out early while receiving adjuvant therapy (\\<6 months).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male ≥ 18 years of age.\n2. Histologically confirmed adenocarcinoma of the prostate without histological variants comprising \\>50% of the sample as determined by academic center central review (including neuroendocrine differentiation, small cell, sarcomatoid, ductal adenocarcinoma, squamous or transitional cell carcinoma).\n3. Must have 3 core biopsies involved with cancer (a minimum of 6 core biopsies must be obtained). Prostate biopsy must be within seven months from screening. Less than 3 core biopsies are allowed if the patient has \\>1 cm or T3 disease on MRI.\n4. Patients must have the following features:\n\n * Gleason ≥ 4+3=7 OR\n * Gleason 3+4=7 AND at least one of the following: PSA \\>20 ng/dL or T3 disease (as determined by MRI).\n5. No evidence of metastatic disease as determined by radionuclide bone scans and CT/MRI. Lymph nodes must be less than 20 mm in the short (transverse) axis.\n6. Participants must be candidates for RP and considered surgically resectable by urologic evaluation.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n8. Participants must have normal organ and marrow function as defined below:\n\n * Hemoglobin ≥ 9.0 g/dL\n * Absolute neutrophil count (ANC) ≥ 1,500/mcL\n * Platelets ≥ 100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start\n * Serum potassium ≥ 3.5 mmol/L\n * Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) (except in subjects with Gilbert's syndrome who have a total bilirubin \\> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible)\n * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN\n * Serum albumin ≥ 3.0 g/dL\n * Serum creatinine \\< 2.0 x ULN\n * PTT≤60\n9. Participant must agree to use a condom (even men with vasectomies) and another effective method of birth control if having sex with a woman of childbearing potential or must agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Participant must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.\n10. Medications known to lower the seizure threshold (see list under APPENDIX D: Representative Medications that May Predispose to Seizure) must be discontinued or substituted at least 1 week prior to study treatment.\n\nExclusion Criteria:\n\n1. Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens (including first-generation antiandrogens, enzalutamide, Apalutamide and others), CYP17 inhibitors (including abiraterone acetate, TAK-700, galeterone, ketoconazole, and others), estrogens, Luteinizing Hormone Releasing Hormone (LHRH) agonist/antagonists. Prior therapy with 5α-reductase inhibitors is allowed. LHRH therapy allowed if begun within 4 weeks of day 1.\n2. Prior chemotherapy, radiation therapy, or immunotherapy for prostate cancer.\n3. Prior systemic treatment with an azole drug within two weeks of start of treatment.\n4. Hypogonadism or severe androgen deficiency as defined by screening serum testosterone \\< 200 ng/dL.\n5. Clinically significant cardiovascular disease within 6 months of study treatment including:\n\n * Severe or unstable angina;\n * Myocardial infarction;\n * Symptomatic congestive heart failure;\n * New York Heart Association (NYHA) class II-IV heart disease;\n * Arterial or venous thromboembolic events (such as pulmonary embolism cerebrovascular accident including transient ischemic attacks);\n * History of clinically significant ventricular arrhythmias (e.g. ventricular tachycardia, ventricular fibrillation, torsades de pointes);\n * Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on screening EKG \\> 470 msec;\n * History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place;\n * Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg). Participants with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy.\n6. History of seizure or any condition or concurrent medication that may predispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to randomization, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect).\n7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Apalutamide, abiraterone acetate, or other study drugs.\n8. Severe hepatic impairment (Child-Pugh Class C).\n9. Active infection (such as human immunodeficiency virus (HIV) or viral hepatitis) or other medical condition that would make prednisone / prednisolone corticosteroid use contraindicated.\n10. History of pituitary or adrenal dysfunction.\n11. Gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug.\n12. Pre-existing condition that warrants long-term corticosteroid use greater than the equivalent of 10 mg prednisone daily. Physiologic replacement is permitted. Topical, intra-articular, or inhaled corticosteroids are permitted.\n13. Concomitant use of medications that may alter pharmacokinetics of abiraterone acetate or Apalutamide.\n14. Individuals with a history of a different malignancy are ineligible except for the following circumstances: 1) individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy, or 2) individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: non-muscle invasive bladder cancer, basal cell or squamous cell carcinoma of the skin.\n15. Major surgery or radiation therapy within 30 days of screening visit. Participants who have had a major surgery within 30 days of screening visit may be eligible provided the treating investigator deems that the participant is at low risk for complications.\n16. Any condition that in the opinion of the investigator would preclude participation in this study."}, 'identificationModule': {'nctId': 'NCT02903368', 'briefTitle': 'Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Phase II Randomized Study Of Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide For Intermediate-High Risk Prostate Cancer Undergoing Prostatectomy', 'orgStudyIdInfo': {'id': '16-223'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1A: AAPL Neoadjuvant Therapy [Part 1]', 'description': 'Eligible Participants will be randomized to receive:\n\nAAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months\n\nPts x weeks to RP', 'interventionNames': ['Drug: Apalutamide', 'Drug: Leuprolide', 'Drug: Prednisone', 'Drug: Abiraterone Acetate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 1B: APL Neoadjuvant Therapy [Part 1]', 'description': 'Eligible Participants will be randomized to receive:\n\nAPL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months', 'interventionNames': ['Drug: Leuprolide', 'Drug: Prednisone', 'Drug: Abiraterone Acetate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2A: AAPL Adjuvant Therapy [Part 2]', 'description': 'Eligible Participants will be randomized to receive:\n\nAAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months', 'interventionNames': ['Drug: Apalutamide', 'Drug: Leuprolide', 'Drug: Prednisone', 'Drug: Abiraterone Acetate']}, {'type': 'NO_INTERVENTION', 'label': 'Arm 2B: Observation [Part 2]'}], 'interventions': [{'name': 'Apalutamide', 'type': 'DRUG', 'otherNames': ['JNJ-56021927', 'ARN-509'], 'armGroupLabels': ['Arm 1A: AAPL Neoadjuvant Therapy [Part 1]', 'Arm 2A: AAPL Adjuvant Therapy [Part 2]']}, {'name': 'Leuprolide', 'type': 'DRUG', 'otherNames': ['Lupron', 'Eligard'], 'armGroupLabels': ['Arm 1A: AAPL Neoadjuvant Therapy [Part 1]', 'Arm 1B: APL Neoadjuvant Therapy [Part 1]', 'Arm 2A: AAPL Adjuvant Therapy [Part 2]']}, {'name': 'Prednisone', 'type': 'DRUG', 'otherNames': ['Deltasone'], 'armGroupLabels': ['Arm 1A: AAPL Neoadjuvant Therapy [Part 1]', 'Arm 1B: APL Neoadjuvant Therapy [Part 1]', 'Arm 2A: AAPL Adjuvant Therapy [Part 2]']}, {'name': 'Abiraterone Acetate', 'type': 'DRUG', 'otherNames': ['Zytiga'], 'armGroupLabels': ['Arm 1A: AAPL Neoadjuvant Therapy [Part 1]', 'Arm 1B: APL Neoadjuvant Therapy [Part 1]', 'Arm 2A: AAPL Adjuvant Therapy [Part 2]']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Mary-Ellen Taplin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mary-Ellen Taplin, MD', 'investigatorFullName': 'Mary-Ellen Taplin, MD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}