An Safety and Efficacy Study of Abiraterone Acetate in Participants With Advanced Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
Condition: Prostate Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone acetate; Glucocorticoid
Intervention description: Abiraterone acetate 1000 milligram (mg) capsule or tablet will be administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study.; Prednisone/prednisolone 5 mg tablet orally twice daily/dexamethasone 0.5 mg tablet orally once daily continuously in 28-day cycle up to disease progression, death, or end of study.
Intervention MeSH terms: Abiraterone Acetate; Glucocorticoids
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate neoplasms; CB7630; Abiraterone acetate; Glucocorticoid; Prednisone; Prednisolone

Summary:

      The purpose of this study is to assess the anti-tumor activities and safety of abiraterone
      acetate in participants with prostate cancer (a disease in which cells in the prostate gland
      [a gland in the male reproductive system found below the bladder and in front of the rectum]
      become abnormal and start to grow uncontrollably, forming tumors) who have failed taxane
      (docetaxel)-based chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma (cancer that begins in cells
             that line certain internal organs and that have secretory properties) of the prostate,
             but not with neuroendocrine differentiation or of small cell histology

          -  Before chemotherapy for prostate cancer with regimen(s) containing paclitaxel or
             docetaxel

          -  Documented prostate-specific antigen (PSA) progression according to PSA working group
             eligibility criteria with a PSA greater than 5 nanogram per milliliter (ng/mL)

          -  Ongoing androgen deprivation with serum testosterone level of less than 50 nanogram
             per deciliter (ng/dL)

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to
             2 (Karnofsky Performance Status greater than or equal 50 percentage)

        Exclusion Criteria:

          -  Active or uncontrolled autoimmune disease that may require corticosteroid therapy

          -  Serious or uncontrolled co-existent non-malignant disease, including active and
             uncontrolled infection

          -  Uncontrolled hypertension

          -  Clinically significant heart disease as evidenced by a myocardial infarction in the
             past 12 months, severe or unstable angina, or New York Heart Association (NYHA) Class
             III or IV heart disease (participants with a history of atherosclerotic vascular
             disease requiring coronary or peripheral artery bypass surgery may be enrolled
             provided the surgery occurred at least 2 years before to enrollment and after
             consultation with a cardiologist to insure that the disease is stable)

          -  History of gastrointestinal disorders (medical disorders or extensive surgery) which
             may interfere with the absorption of the study medication