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A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III EFFICACY AND SAFETY STUDY OF DAROLUTAMIDE (ODM-201) IN MEN WITH HIGH-RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

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Trial Profile

A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III EFFICACY AND SAFETY STUDY OF DAROLUTAMIDE (ODM-201) IN MEN WITH HIGH-RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Nov 2023

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At a glance

  • Drugs Darolutamide (Primary)
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ARAMIS
  • Sponsors Bayer; Orion Pharma

    • Most Recent Events

    • 11 Nov 2023 Results pooled post hoc analysis from TITAN and 806 SPARTAN assessing efficacy, safety and wellbeing in older patients with advanced prostate cancer published in the British Journal of Cancer
    • 24 Oct 2023 Results effect of darolutamide on Health-related quality of life (HRQoL) deterioration-free survival by PSA decline , presented at the 48th European Society for Medical Oncology Congress
    • 12 Oct 2023 According to a Bayer media release, the company will present new data on health-related quality of life (HRQoL) deterioration-free survival (DetFS) by PSA decline at the upcoming European Society for Medical Oncology (ESMO) Congress taking place in Madrid, Spain from October 20-24, 2023.
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