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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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Trial Profile

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: 28 Jun 2025

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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

  • 20 Jun 2025 According to Orion media release, the company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended darolutamide plus androgen deprivation therapy (ADT) for marketing authorisation in the EU for the treatment of patients with mHSPC. The CHMP recommendation is based on positive results from this trial. A final decision on marketing authorisation from the European Commission is anticipated in the coming months.
  • 03 Jun 2025 According to a Bayer media release, Fred Saad, M.D is the principle investigator of the trial.
  • 03 Jun 2025 According to a Bayer media release, company announced that based on the results of this trial the U.S. Food and Drug Administration (FDA) has approved its oral androgen receptor inhibitor NUBEQA (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer

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