A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)

CR100900

The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone \[LHRH\] agonists or surgical castration).

2013-02-12

2016-10-31

2022-02-13

Completed

Early phase I

1209

Inclusion Criteria: * Newly diagnosed metastatic prostate cancer within 3 months prior to randomization with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology * Distant metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan * At least 2 of the following high-risk prognostic factors: Gleason score of greater than or equal to (\>=8); presence of 3 or more lesions on bone scan; presence of measurable visceral (excluding lymph node disease) metastasis on CT or MRI Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 scan * Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2 * Adequate hematologic, hepatic, and renal function * Agrees to protocol-defined use of effective contraception Exclusion Criteria: * Active infection or other medical condition that would make prednisone use contraindicated * Any chronic medical condition requiring a higher systemic dose of corticosteroid than 5 mg prednisone per day * Pathological finding consistent with small cell carcinoma of the prostate * Known brain metastasis * Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer (the following exception are permitted): up to 3 months of androgen deprivation therapy (ADT) with lutenizing hormone releasing hormone agonists or antagonists or orchiectomy with or without concurrent anti-androgens prior Cycle 1 Day 1; participants may have one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 28 days prior to Cycle 1 Day 1)

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2023-03-13