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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)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 111 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. New version filed on ClinicalTrials.gov
  2. Study sites revised (173)v110
  3. 15 versions Re-verified since May 22, 2025, no change to tracked fieldsv95-v109
  4. Primary completion date: Mar 1, 2018 to Mar 19, 2018
    • Study completion date: Dec 1, 2027 to Dec 31, 2027
    • Start date: Nov 1, 2014 to Nov 26, 2014
    v94
  5. Primary completion date: Mar 19, 2018 to Mar 1, 2018
    • Study completion date: Dec 31, 2027 to Dec 1, 2027
    • Start date: Nov 26, 2014 to Nov 1, 2014
    v93
Show 31 earlier versionsHide 31 earlier versions
  1. 2 versions Re-verified since Jan 8, 2025, no change to tracked fieldsv91-v92
  2. Primary completion date: Mar 2018 to Mar 19, 2018
    • Study completion date: Dec 2027 to Dec 31, 2027
    • Start date: Nov 2014 to Nov 26, 2014
    v90
  3. Primary completion date: Mar 19, 2018 to Mar 2018
    • Study completion date: Dec 31, 2025 to Dec 2027
    • Start date: Nov 26, 2014 to Nov 2014
    v89
  4. 6 versions Re-verified since Apr 23, 2024, no change to tracked fieldsv83-v88
  5. Study sites: 175 to 173
    • Primary completion date: Mar 2018 to Mar 19, 2018
    • Study completion date: Dec 2025 to Dec 31, 2025
    • Start date: Nov 2014 to Nov 26, 2014
    v82
  6. Study completion date: Dec 2026 to Dec 2025v81
  7. Re-verified, no change to tracked fieldsv80
  8. Primary completion date: Mar 19, 2018 to Mar 2018
    • Study completion date: Dec 31, 2024 to Dec 2026
    • Start date: Nov 26, 2014 to Nov 2014
    v79
  9. 2 versions Re-verified since Oct 10, 2023, no change to tracked fieldsv77-v78
  10. Study completion date: Oct 11, 2023 to Dec 31, 2024
    • Study sites revised (175)
    v76
  11. 5 versions Re-verified since May 3, 2023, no change to tracked fieldsv71-v75
  12. Study sites: 181 to 175
    • Primary completion date: Mar 2018 to Mar 19, 2018
    • Study completion date: Oct 2023 to Oct 11, 2023
    • Start date: Nov 2014 to Nov 26, 2014
    v70
  13. Primary completion date: Mar 19, 2018 to Mar 2018
    • Study completion date: Apr 5, 2023 to Oct 2023
    • Start date: Nov 26, 2014 to Nov 2014
    v69
  14. 7 versions Re-verified since Aug 2, 2022, no change to tracked fieldsv62-v68
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 \[gland that makes fluid that aids movement of sperm\]).
Trial Details
NCT Number NCT02257736
Lead Sponsor Aragon Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Prostatic Neoplasms
Related terms Prostatic Neoplasms
Enrollment 982 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov