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A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

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A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2024

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At a glance

  • Drugs Darolutamide (Primary) ; Luteinising hormone modulators
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ARANOTE
  • Sponsors Bayer

    • Most Recent Events

    • 26 Sep 2024 According to an Orion media release, the company announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the oral androgen receptor inhibitor (ARi) darolutamide.
    • 16 Sep 2024 Results presented in an Orion Media Release.
    • 16 Sep 2024 According to a Bayer media release, Results from the investigational pivotal Phase III ARANOTE trial as a late-breaking oral presentation at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain and published simultaneously in The Journal of Clinical Oncology.

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