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Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion moved earlier from Sep 30, 2026 to Jun 9, 2026v30
  2. Re-verified, no change to tracked fieldsv29
  3. Primary completion pushed from Jun 30, 2026 to Sep 30, 2026v28
  4. 8 versions Re-verified since Oct 28, 2025, no change to tracked fieldsv20-v27
  5. Primary completion date: Dec 31, 2025 to Jun 30, 2026v19
Show 17 earlier versionsHide 17 earlier versions
  1. Primary completion date: Jun 30, 2025 to Dec 31, 2025v18
  2. Primary completion date: May 31, 2028 to Jun 30, 2025v17
  3. Re-verified, no change to tracked fieldsv16
  4. Start date: Dec 9, 2020 to Mar 1, 2021v15
  5. Enrollment target: estimated 810 to confirmed 27
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 115 of 115 sites
    v14
  6. Study sites: 112 to 115v13
  7. Study sites: 108 to 112v12
  8. Site details revised at 5 of 108 sitesv11
  9. Study sites: 106 to 108v10
  10. Site details revised at 1 of 106 sitesv9
  11. Study sites: 105 to 106v8
  12. Study sites: 98 to 105v7
  13. Study sites: 94 to 98v6
  14. Study sites: 80 to 94v5
  15. Study sites: 13 to 80v4
  16. Study sites: 1 to 13v3
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 10, 2020 to Dec 9, 2020
    • Secondary endpoints revised (9)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This phase III trial compares the effect of adding darolutamide to ADT versus ADT alone after surgery for the treatment of high-risk prostate cancer. ADT reduces testosterone levels in the blood. Testosterone is a hormone made mainly in the testes and is needed to develop and maintain male sex characteristics, such as facial hair, deep voice, and muscle growth. It also plays role in prostate cancer development. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. Giving darolutamide with ADT may work better in eliminating or reducing the size of the cancer and/or prevent it from returning compared to ADT alone in patients with prostate cancer.
Trial Details
NCT Number NCT04484818
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Prostate Carcinoma
Related terms Prostatic Neoplasms
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov