An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: Apalutamide; Abiraterone acetate; Prednisone; Placebo
Intervention description: Participants will receive 240 mg (4*60 mg tablets) of apalutamide once daily orally.; Participants will receive 1000 mg (4*250 mg tablets) of abiraterone acetate (AA) once daily orally.; Participants will receive 5 mg tablet of prednisone twice daily orally.; Participants will receive matching placebo to apalutamide once daily orally.
Intervention MeSH terms: Prednisone; Abiraterone Acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 982.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostatic neoplasms; JN56021927; ZYTIGA; Prednisone; Abiraterone acetate; Apalutamide

Summary:

      The purpose of this study is to compare the radiographic progression-free survival (rPFS) of
      apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone
      (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any
      chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate
      cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of
      sperm]).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adenocarcinoma of the prostate

          -  Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic
             lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans
             (visceral or lymph node disease). If lymph node metastasis is the only evidence of
             metastasis, it must be greater than or equal to (>=) 2 centimeter (cm) in the longest
             diameter

          -  Castration-resistant prostate cancer demonstrated during continuous androgen
             deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the
             last androgen deprivation therapy (PSA) >= 2 nanogram per milliliters (ng/mL)

          -  Participants who received a first generation anti-androgen (eg, bicalutamide,
             flutamide, nilutamide) must have at least a 6-week washout prior to randomization and
             must show continuing disease (PSA) progression (an increase in PSA) after the washout
             period

          -  Prostate cancer progression documented by prostate-specific antigen (PSA) according to
             the Prostate Cancer Clinical Trials Working Group (PCWG2) or radiographic progression
             of soft tissue according to modified Response Evaluation Criteria in Solid Tumors,
             version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone
             according to PCWG2

          -  Participants who cross-over from Prednisone alone to open-label apalutamide plus AAP
             should still be in the double-blind phase of the study, should be receiving AAP alone
             and should have ECOG 0-1-2.

        Exclusion Criteria:

          -  Small cell or neuroendocrine carcinoma of the prostate

          -  Known brain metastases

          -  Prior chemotherapy for prostate cancer, except if administered in the
             adjuvant/neoadjuvant setting

          -  Previously treated with ketoconazole for prostate cancer for greater than 7 days

          -  Therapies that must be discontinued or substituted at least 4 weeks prior to
             randomization include the following: a) Medications known to lower the seizure
             threshold, b) Herbal and non-herbal products that may decrease PSA levels (example
             [eg], saw palmetto, pomegranate) or c) Any investigational agent

          -  At Screening need for parenteral or oral opioid analgesics (eg, codeine,
             dextropropoxyphene)