A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone; Leuprolide; Prednisone
Intervention description: Abiraterone acetate tablets will be administered orally at a total dose of 1000 milligram (mg) per day at least 1 hour before a meal or 2 hours after a meal for 24 weeks in Group 1 and from Week 13 to Week 24 for Group 2.; Leuprolide acetate will be administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks in Group 1 and Group 2.; Prednisone tablets will be administered orally as 5 mg once daily for 24 weeks in Group 1 and from Week 13 to Week 24 for Group 2.
Intervention MeSH terms: Prednisone; Leuprolide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate cancer; Abiraterone acetate; Leuprolide acetate; Prednisone; CB7630; Testosterone

Summary:

      The purpose of this study is to evaluate safety and efficacy of abiraterone acetate plus
      leuprolide acetate and prednisone, versus leuprolide acetate alone in male participants with
      prostate cancer (a disease in which cells in the prostate gland become abnormal and start to
      grow uncontrollably, forming tumors) who are suitable candidates for prostatectomy (surgery
      to remove all or part of the prostate gland).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate

          -  At least three core biopsies positive for prostate cancer (a minimum of 6 core
             biopsies must be obtained at baseline). A prostate biopsy within 6 months from
             Screening is allowed for entry requirements

          -  At least one of the following features: prostate specific antigen (PSA) greater than
             (>) 10 nanogram per milliliter (ng/ml); PSA velocity >2 ng/ml per /year (defined as a
             rise in PSA of >2 ng/ml in the preceding 12 month period); Gleason score greater than
             or equal to (>=) 7 (4+3); Gleason score 6 if either PSA >=10 ng/ml or PSA velocity >=2
             ng/ml/year

          -  Serum testosterone >200 nanogram/deciliter

          -  Participant and urologist must agree that participant is suitable for prostatectomy

        Exclusion Criteria:

          -  Serious or uncontrolled co-existent, non-malignant disease, including active and
             uncontrolled infection

          -  Abnormal liver function consisting of any of the following: serum bilirubin >= 1.5 *
             upper limit of normal (ULN); aspartate aminotransferase or alanine aminotransferase
             >=2.5 * ULN

          -  Uncontrolled hypertension within the Screening period (systolic blood pressure >= 160
             millimeter of mercury [mmHg] or diastolic BP >= 95 mmHg)

          -  Requirement for corticosteroids greater than the equivalent of 5 milligram of
             prednisone daily

          -  Participants with active or symptomatic viral hepatitis or chronic liver disease or
             clinically significant heart disease or as evidenced by myocardial infarction, or
             arterial thrombotic events in the past 6 months, severe or unstable angina, or New
             York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction
             measurement of < 50 percent at Baseline or history of gastrointestinal disorders
             (medical disorders or extensive surgery) which may interfere with the absorption of
             the study drug or history of pituitary or adrenal dysfunction