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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: 22 Sep 2025

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At a glance

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

Most Recent Events

  • 21 Jul 2025 According to Orion media release, based on positive results from ARANOTE trial, the European Commission has granted marketing authorization in the European Union (EU) for Nubeqa™ (darolutamide), an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
  • 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.

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