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A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer

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Trial Profile

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Jun 2026

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At a glance

  • Drugs Darolutamide (Primary) ; Gallium (68Ga) gozetotide (Primary) ; Piflufolastat F18 (Primary) ; Androgen receptor antagonists
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ARASTEP
  • Sponsors Bayer

Most Recent Events

  • 19 Nov 2025 Status changed from recruiting to active, no longer recruiting.
  • 21 May 2025 According to a Bayer media release, data from this study will be presented at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago from May 30-June 3.
  • 16 Apr 2025 According to a Bayer media release, data from this study will be presented at the upcoming American Urological Association (AUA) Annual Meeting taking place in Las Vegas from April 26-29, 2025.

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