A Study of Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy
Condition: Prostate Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone acetate; Placebo; Prednisone
Intervention description: Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily; Placebo (4 tablets) taken orally once daily; Prednisone 5 mg tablet taken orally twice daily
Intervention MeSH terms: Prednisone; Abiraterone Acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 214.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate neoplasms; Prostate cancer; Metastatic castration resistant prostate cancer; Abiraterone acetate; JNJ-212082

Summary:

      The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate when
      co-administered with prednisone in Asian patients with metastatic castration-resistant
      prostate cancer (mCRPC) who have failed docetaxel-based chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate except
             neuroendocrine carcinoma including small cell carcinoma

          -  Disease progressed on or after prior docetaxel-containing chemotherapy

          -  Prior 1 or 2 cytotoxic chemotherapy regimens for metastatic castration-resistant
             prostate cancer, at least 1 of which contains docetaxel

          -  Documented prostate cancer progression as documented by prostate specific antigen
             progression according to Prostate Specific Antigen Working Group criteria or
             radiographic progression in soft tissue or bone

          -  Surgically or medically castrated, with serum testosterone level <50 ng/dL (1.7
             nmol/L)

          -  Eastern Cooperative Oncology Group performance status score of <=2

          -  Protocol-defined laboratory values

          -  Agrees to protocol-defined use of effective contraception

        Exclusion Criteria:

          -  Active infection or other medical condition that would make prednisone
             (corticosteroid) use contraindicated

          -  Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg
             prednisone twice daily

          -  Pathological finding consistent with neuroendocrine carcinoma of prostate including
             small cell carcinoma

          -  Uncontrolled hypertension (systolic BP >=160 mmHg or diastolic BP >=95 mmHg; patients
             with a history of hypertension are allowed provided blood pressure is controlled by
             anti-hypertensive therapy)

          -  Active or symptomatic viral hepatitis or chronic liver disease, have a known infection
             with human immunodeficiency virus and/or hepatitis B virus or hepatitis C virus

          -  History of pituitary or adrenal dysfunction.

          -  Clinically significant heart disease as evidenced by myocardial infarction, or
             arterial thrombotic events in the past 6 months, severe or unstable angina, or New
             York Heart Association Class III or IV heart disease or cardiac ejection fraction
             measurement of <50% at baseline

          -  Atrial fibrillation, or other cardiac arrhythmia requiring therapy

          -  Other malignancy within past 3 years (except basal or nonmetastatic squamous cell
             carcinoma of the skin)

          -  Known brain metastasis

          -  Prior therapy with abiraterone acetate or other CYP17 inhibitor(s), or investigational
             agent(s) targeting the androgen receptor for metastatic prostate cancer

          -  Prior therapy with ketoconazole for prostate cancer

          -  Surgery or local prostatic intervention within 30 days of the first dose

          -  Radiotherapy, chemotherapy, or immunotherapy within 30 days, or single fraction of
             palliative radiotherapy within 14 days of administration of Cycle 1 Day 1

          -  Any acute toxicities due to prior chemotherapy and/or radiotherapy that have not
             resolved to a National Cancer Institute-Common Terminology Criteria for Adverse Events
             grade of <=1 (chemotherapy induced alopecia and grade 2 peripheral neuropathy is
             allowed)

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within 30 days of Cycle 1 Day 1

          -  Anti-androgen treatment must not be given within 4 weeks (flutamide) or 6 weeks
             (bicalutamide or nilutamide) prior to Cycle 1 Day 1

          -  Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole) within 4
             weeks prior to Cycle 1 Day 1

          -  Has known allergies, hypersensitivity, or intolerance to abiraterone acetate or its
             excipients

          -  Has contraindications to the use of prednisone per local prescribing information

          -  Has any condition that, in the opinion of the investigator, would make participation
             not be in the best interest (eg, compromise the well-being) of the patient or that
             could prevent, limit, or confound the protocol-specified assessments