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A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC

Study acronym: TITAN
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 123 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Publications: details revised at 12 of 12 entries
  2. Study sites revised (220)v122
  3. 3 versions Re-verified since May 7, 2026, no change to tracked fieldsv119-v121
  4. Study sites: 222 to 220v118
  5. 15 versions Re-verified since Jan 8, 2025, no change to tracked fieldsv103-v117
Show 29 earlier versionsHide 29 earlier versions
  1. Study sites revised (222)v102
  2. 2 versions Re-verified since Oct 23, 2024, no change to tracked fieldsv100-v101
  3. Study completion date: Sep 5, 2025 to Dec 31, 2027v99
  4. Re-verified, no change to tracked fieldsv98
  5. Primary completion date: Sep 2020 to Sep 7, 2020
    • Study completion date: Sep 2025 to Sep 5, 2025
    • Start date: Nov 2015 to Nov 27, 2015
    v97
  6. Primary completion date: Sep 7, 2020 to Sep 2020
    • Study completion date: Sep 5, 2024 to Sep 2025
    • Start date: Nov 27, 2015 to Nov 2015
    v96
  7. 2 versions Re-verified since May 22, 2024, no change to tracked fieldsv94-v95
  8. Study sites revised (222)v93
  9. 2 versions Re-verified since Feb 27, 2024, no change to tracked fieldsv91-v92
  10. Primary completion date: Sep 2020 to Sep 7, 2020
    • Study completion date: Sep 2024 to Sep 5, 2024
    • Start date: Nov 2015 to Nov 27, 2015
    v90
  11. Primary completion date: Sep 7, 2020 to Sep 2020
    • Study completion date: May 31, 2024 to Sep 2024
    • Start date: Nov 27, 2015 to Nov 2015
    v89
  12. 9 versions Re-verified since Apr 12, 2023, no change to tracked fieldsv80-v88
  13. Study sites: 221 to 222v79
  14. Re-verified, no change to tracked fieldsv78
  15. Study sites: 222 to 221v77
  16. 3 versions Re-verified since Sep 27, 2022, no change to tracked fieldsv74-v76
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.
Trial Details
NCT Number NCT02489318
Lead Sponsor Aragon Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 1,052 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov