A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)
Condition: Prostate Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone acetate; Prednisone; Androgen deprivation therapy (ADT); Abiraterone acetate Placebo; Prednisone Placebo
Intervention description: Abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day until disease progression, withdrawal of consent or unacceptable toxicity.; Prednisone 5 mg capsule will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.; All participants will receive stable regimen of ADT, that is, lutenizing hormone releasing hormone (LHRH) agonists or surgical castration according to local guidelines until disease progression, withdrawal of consent or unacceptable toxicity.; Placebo matched to abiraterone acetate will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.; Placebo matched to prednisone will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
Intervention MeSH terms: Prednisone; Abiraterone Acetate; Androgens
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1209.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate neoplasms; Prostate cancer; Metastatic prostate cancer; Abiraterone acetate; ZYTIGA; Prednisone; Androgen deprivation therapy

Summary:

      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).
    

Eligibility criteria:

        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)