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)

Janssen-Cilag International NV0 sites1,270 target enrollmentDecember 11, 2012

Overview

No summary available.

Registry

who.int

Start Date

December 11, 2012

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•1\. 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
•2\. Distant metastatic disease documented by positive bone scan or metastatic lesions on computed tomography or magnetic resonance imaging scan
•3\. At least two of the following high\-risk prognostic factors: Gleason score of \>\=8; presence of 3 or more lesions on bone scan; presence of measurable visceral (excluding lymph node disease) metastasis on CT or MRI scan based on RECIST 1\.1\.
•4\. Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2
•5\. Adequate hematologic, hepatic, and renal function
•6\. Agrees to protocol\-defined use of effective contraception
•Treatment Criteria for Crossover to the Open\-label Extension Phase:
•1\. Subject is receiving study drug and is willing and able to provide written informed consent to crossover to open\-label abiraterone acetate plus prednisone therapy
•2\. Adequate hepatic and safety laboratory assessments below within 4
•weeks of OLE Phase Cycle 1 Day 1:

•1\. Active infection or other medical condition that would make prednisone use contraindicated
•2\. Any chronic medical condition requiring a higher systemic dose of corticosteroid than 5 mg prednisone per day
•3\. Pathological finding consistent with small cell carcinoma of the prostate
•4\. Known brain metastasis
•5\. Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer; the following exceptions are permitted: up to 3 months of androgen deprivation therapy (ADT) with lutenizing hormone releasing hormone agonists or orchiectomy with or without concurrent anti\-androgens prior to 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, all adverse events associated with these procedures must be resolved at least to Grade 1 by Cycle 1 Day 1\.