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An Open-label, Randomised, Phase-I, Multi-Centre Study to Investigate the Biological Effects of Saruparib (AZD5305) Alone, Darolutamide Alone, and in Combination Given Prior to Radical Prostatectomy in Men With Newly Diagnosed Prostate Cancer (ASCERTAIN)

Trial Profile

An Open-label, Randomised, Phase-I, Multi-Centre Study to Investigate the Biological Effects of Saruparib (AZD5305) Alone, Darolutamide Alone, and in Combination Given Prior to Radical Prostatectomy in Men With Newly Diagnosed Prostate Cancer (ASCERTAIN)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 10 Jul 2025

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At a glance

  • Drugs Darolutamide (Primary) ; Saruparib (Primary)
  • Indications Prostate cancer
  • Focus Pharmacodynamics
  • Acronyms ASCERTAIN
  • Sponsors AstraZeneca

Most Recent Events

  • 02 Jul 2025 Planned End Date changed from 14 Nov 2025 to 11 Feb 2026.
  • 02 Jul 2025 Planned primary completion date changed from 14 Nov 2025 to 11 Feb 2026.
  • 14 Oct 2024 Planned End Date changed from 25 Feb 2025 to 14 Nov 2025.

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