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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: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Mar 2026

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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

  • 27 Feb 2026 Status changed from active, no longer recruiting to completed.
  • 21 Aug 2025 According to Orion media release, company has announced that Health Canada has granted marketing authorization for its oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). The marketing authorization is based on recent results from the Phase III ARANOTE trial.
  • 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).

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