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Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

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

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv43
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 93 of 93 sites
    v42
  3. Study sites revised (93)v41
  4. Study sites: 92 to 93v40
  5. Study sites: 91 to 92v39
Show 37 earlier versionsHide 37 earlier versions
  1. Study sites: 90 to 91v38
  2. Study sites: 89 to 90v37
  3. Study sites: 88 to 89v36
  4. Study sites: 86 to 88v35
  5. Study sites: 85 to 86v34
  6. Study sites: 83 to 85v33
  7. Study sites: 75 to 83v32
  8. Study sites: 74 to 75v31
  9. Study sites: 65 to 74
    • Secondary endpoints: 10 to 8
    • Study description expanded, about 252 words
    v30
  10. Study sites: 62 to 65v29
  11. Study sites: 61 to 62v28
  12. Study sites: 60 to 61v27
  13. Study sites: 59 to 60v26
  14. Study sites: 58 to 59v25
  15. Study sites revised (58)v24
  16. Study sites: 57 to 58v23
  17. Study sites: 56 to 57v22
  18. Study sites: 55 to 56v21
  19. Study sites: 54 to 55v20
  20. Site details revised at 1 of 54 sitesv19
  21. Study sites: 48 to 54v18
  22. Site details revised at 1 of 48 sitesv17
  23. Site details revised at 2 of 48 sitesv16
  24. Site details revised at 2 of 48 sitesv15
  25. Study sites: 46 to 48v14
  26. Site details revised at 7 of 46 sitesv13
  27. Study sites: 31 to 46v12
  28. Eligibility criteria expanded, about 263 words
    • Secondary endpoints revised (10)
    • Site contacts updated at 2 of 31 sites
    • Collaborators: 4 to 6
    v11
  29. Site details revised at 5 of 31 sitesv10
  30. Site details revised at 3 of 31 sitesv9
  31. Re-verified, no change to tracked fieldsv8
  32. Site details revised at 6 of 31 sitesv7
  33. Study sites: 6 to 31v6
  34. Study sites: 3 to 6v5
  35. Study sites: 2 to 3v4
  36. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    v3
  37. Start date: Jan 31, 2020 to Mar 31, 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to determine the effectiveness of darolutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at very high risk of recurrence.
Trial Details
NCT Number NCT04136353
Lead Sponsor University of Sydney
Collaborators: Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Bayer, Cancer Trials Ireland, Canadian Cancer Trials Group, Memorial Sloan Kettering Cancer Center, Prostate Cancer Clinical Trials Consortium
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 1,100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov