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) (NCT02257736)
🩺 Plain-English Summary (8th-Grade Level)
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 \[gland that makes fluid that aids movement of sperm\]).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (6 items).
Location: Clinical Research Facility — Phoenix, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (173 Sites)
- Clinical Research Facility — Phoenix, Arizona
- Clinical Research Facility — La Mesa, California
- Clinical Research Facility — Los Angeles, California
- Clinical Research Facility — Modesto, California
- Clinical Research Facility — San Diego, California
- Clinical Research Facility — San Francisco, California
- Clinical Research Facility — Santa Barbara, California
- Clinical Research Facility — Aurora, Colorado
- Clinical Research Facility — Denver, Colorado
- Clinical Research Facility — Jensen Beach, Florida
- Clinical Research Facility — Lakeland, Florida
- Clinical Research Facility — New Port Richey, Florida
- Clinical Research Facility — Ocala, Florida
- Clinical Research Facility — Atlanta, Georgia
- Clinical Research Facility — Melrose, Illinois
- Clinical Research Facility — Niles, Illinois
- Clinical Research Facility — Marrero, Louisiana
- Clinical Research Facility — New Orleans, Louisiana
- Clinical Research Facility — Shreveport, Louisiana
- Clinical Research Facility — Auburn, Maine
- Clinical Research Facility — Baltimore, Maryland
- Clinical Research Facility — St Louis, Missouri
- Clinical Research Facility — Omaha, Nebraska
- Clinical Research Facility — Las Vegas, Nevada
- Clinical Research Facility — Albany, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.