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An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Jun 30, 2026 → Mar 1, 2027
See other at-risk trials from Aragon Pharmaceuticals, Inc.

Record History

The 50 most recent of 122 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria shortened, about 12 words
    • Secondary endpoints: details revised at 2 of 8 entries
    • Study sites revised (263)
  2. Primary completion pushed from Jun 30, 2026 to Mar 1, 2027v121
  3. Re-verified, no change to tracked fieldsv120
  4. Study sites revised (263)v119
  5. 3 versions Re-verified since Mar 18, 2026, no change to tracked fieldsv116-v118
Show 43 earlier versionsHide 43 earlier versions
  1. Study sites: 262 to 263v115
  2. Study sites revised (262)v114
  3. 4 versions Re-verified since Oct 9, 2025, no change to tracked fieldsv110-v113
  4. Study sites revised (262)v109
  5. Re-verified, no change to tracked fieldsv108
  6. Primary endpoint revised
    • Secondary endpoints revised (8)
    v107
  7. 14 versions Re-verified since Jun 18, 2024, no change to tracked fieldsv93-v106
  8. Primary completion date: Jun 28, 2024 to Jun 30, 2026v92
  9. 4 versions Re-verified since Jan 30, 2024, no change to tracked fieldsv88-v91
  10. Primary completion date: Jun 2024 to Jun 28, 2024
    • Study completion date: Dec 2028 to Dec 29, 2028
    • Start date: Nov 2015 to Nov 19, 2015
    v87
  11. Primary completion date: Jun 28, 2024 to Jun 2024
    • Study completion date: Oct 6, 2026 to Dec 2028
    • Start date: Nov 19, 2015 to Nov 2015
    v86
  12. 2 versions Re-verified since Oct 10, 2023, no change to tracked fieldsv84-v85
  13. Primary completion date: Jun 2024 to Jun 28, 2024
    • Study completion date: Oct 2026 to Oct 6, 2026
    • Start date: Nov 2015 to Nov 19, 2015
    v83
  14. Primary completion date: Jun 28, 2024 to Jun 2024
    • Study completion date: Oct 6, 2026 to Oct 2026
    • Start date: Nov 19, 2015 to Nov 2015
    v82
  15. 4 versions Re-verified since May 3, 2023, no change to tracked fieldsv78-v81
  16. Primary completion date: Jun 2024 to Jun 28, 2024
    • Study completion date: Oct 2026 to Oct 6, 2026
    • Start date: Nov 2015 to Nov 19, 2015
    v77
  17. Primary completion date: Jun 28, 2024 to Jun 2024
    • Study completion date: Oct 6, 2026 to Oct 2026
    • Start date: Nov 19, 2015 to Nov 2015
    v76
  18. Re-verified, no change to tracked fieldsv75
  19. Primary completion date: Dec 30, 2022 to Jun 28, 2024
    • Study sites: 261 to 262
    v74
  20. Re-verified, no change to tracked fieldsv73
  • 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 apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival (MFS) based on conventional imaging assessed by blinded independent central review (BICR).
Trial Details
NCT Number NCT02531516
Lead Sponsor Aragon Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Prostatic Neoplasms
Related terms Prostatic Neoplasms
Enrollment 1,503 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov