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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: 20 May 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

    • 16 May 2024 According to a Bayer media release, post hoc analysis from this study will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, United States, from May 31-June 4, 2024.
    • 15 May 2024 This trial has been completed in Spain (End date:2023-04-11) according to European Clinical Trials Database record.
    • 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
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