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About
The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study also evaluated the safety of enzalutamide plus ADT in mHSPC.
Full description
Following unblinding at the end of the double-blind period and demonstration of a statistically significant advantage of enzalutamide over placebo when added to ADT as assessed by the primary endpoint of rPFS, subjects were eligible to transition to an open-label portion of the study.
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Inclusion criteria
Inclusion Criteria for Open-Label Extension:
Exclusion criteria
Subject has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted):
Subject had a major surgery within 4 weeks prior to day 1.
Subject received treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks prior to day 1.
Subject received treatment with estrogens, cyprotoerone acetate or androgens within 4 weeks prior to day 1.
Subject received treatment with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to day 1, intended for the treatment of prostate cancer.
Subject received treatment with herbal medications that have known hormonal antiprostate cancer activity and/or are known to decrease PSA levels within 4 weeks prior to day 1.
Subject received prior aminoglutethimide, ketoconazole, abiraterone acetate or enzalutamide for the treatment of prostate cancer or participation in a clinical study of an investigational agent that inhibits the AR or androgen synthesis (e.g., TAK-700, ARN-509, ODM-201).
Subject has known or suspected brain metastasis or active leptomeningeal disease.
Subject has absolute neutrophil count < 1500/μL, platelet count < 100000/μL or hemoglobin < 10 g/dL (6.2 mmol/L).
Subject has total bilirubin (TBL) ≥ 1.5 x the upper limit of normal (ULN) (except subjects with documented Gilbert's disease), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 x the ULN .
Subject has creatinine > 2 mg/dL (177 μmol/L).
Subject has albumin < 3.0 g/dL (30 g/L).
Subject has a history of seizure or any condition that may predispose to seizure.
Subject has history of loss of consciousness or transient ischemic attack within 12 months prior to day 1.
Subject has clinically significant cardiovascular disease.
Subject received bisphosphonates or denosumab within 2 weeks prior to day 1 unless administered at stable dose or to treat diagnosed osteoporosis
Exclusion Criteria for Open-Label Extension:
Primary purpose
Allocation
Interventional model
Masking
1,150 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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