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A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer

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Trial Profile

A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Mar 2024

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At a glance

  • Drugs Darolutamide (Primary) ; Antiandrogens; Docetaxel
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ARASENS
  • Sponsors Bayer

    • Most Recent Events

    • 27 Jan 2024 Results comparing rates of hospitalizations and length of hospital stay (LoS) per patient due to any reason, and due to adverse events (AE) during or post docetaxel using data from ARASENS,presented at the 2024 Genitourinary Cancers Symposium
    • 17 Jan 2024 According to a Bayer media release, company will present new data from this study at the upcoming American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, taking place January 25-27, 2024 in San Francisco, California.
    • 24 Oct 2023 Results assessing prostate-specific antigen outcomes in these patient subgroups, presented at the 48th European Society for Medical Oncology Congress.
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