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Randomized Phase II Trial on Short Term Darolutamide Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer

Study acronym: DARIUS
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 43 words
    • Secondary endpoints: details revised at 14 of 31 entries
    • Site details revised at 1 of 10 sites
    • Study description expanded, about 2 words
  2. Primary completion date: Aug 2025 to Dec 2026v4
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: May 2025 to Aug 2025
    • Study completion date: Nov 2029 to Feb 2030
    • Start date changed from estimate of Nov 2022 to Feb 24, 2023
    • Site details revised at 10 of 10 sites
  4. Start date: Aug 2022 to Nov 2022v2 Show 4 more changesShow less
    • Primary completion date: Feb 2025 to May 2025
    • Study completion date: Aug 2029 to Nov 2029
    • Eligibility criteria revised
    • Study title shortened, about 1 word
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Randomized non-comparative phase II trial to assess the preliminary signs of antitumor activity of darolutamide plus radiation therapy in patients with unfavorable intermediate risk prostate cancer.
Trial Details
NCT Number NCT05346848
Lead Sponsor Institut Bergonié
Collaborators: Bayer
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov