An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
Condition: Prostatic Neoplasms; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone acetate; Prednisone
Intervention description: Abiraterone acetate oral tablets 250 milligram (mg) each will be administered at a total dose of 1000 mg until documented disease progression or unacceptable toxicity.; Prednisone/Prednisolone 5 mg tablet will be taken orally twice daily.
Intervention MeSH terms: Prednisone; Abiraterone Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostatic Neoplasms; Prostate cancer; Abiraterone acetate; CB7630; Prednisone

Summary:

      The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in
      participants with advanced prostate cancer (a disease in which cells in the prostate gland
      become abnormal and start to grow uncontrollably, forming tumors).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma (malignant epithelial tumor
             with a glandular organization)of the prostate (a gland in the male reproductive system
             found below the bladder and in front of the rectum), but not with neuroendocrine
             (specialized neurons that produce hormones, such as neuropeptides or biogenic amines)
             differentiation or of small cell histology

          -  Prior chemotherapy (treatment of disease, usually cancer, by chemical agents) for
             prostate cancer with regimen(s) containing docetaxel

          -  Documented prostate specific antigen (PSA) progression according to Prostate Specific
             Antigen Working Group (PSAWG) eligibility criteria with a PSA more than (>) 5 nanogram
             per milliliter (ng/mL) or objective progression by Response Evaluation Criteria in
             Solid Tumors (RESIST) criteria

          -  Ongoing androgen deprivation with serum testosterone less than (<) 50 nanogram per
             deciliter (ng/dL)

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of less than equal to
             (<=) 2 (Karnofsky Performance Status >= 50 percent)

        Exclusion Criteria:

          -  Active or uncontrolled autoimmune disease (disorder in which a person's immune system
             attacks parts of his or her own body) that may require corticosteroid therapy

          -  Serious or uncontrolled co-existent non-malignant disease, including active and
             uncontrolled infection

          -  Uncontrolled hypertension (high blood pressure)

          -  Hemoglobin <=9.0 gram per deciliter (g/dL) without growth factor or transfusion
             support

          -  Abnormal liver (large organ that helps in many body functions, including digestion,
             metabolism, and storage of substances) function