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A Trial Comparing Docetaxel 75 mg/m2 (3w) Versus Docetaxel 50 mg/m2 (2w) in Combination With Darolutamide + ADT in mHSPC Patients

Study acronym: ARASAFE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study completion moved earlier from Jan 2027 to Dec 2026
    • Primary completion date changed from estimate of Jul 2025 to Jul 3, 2025
    • Site details revised at 3 of 43 sites
    v9
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 44 to 43
    v8
  3. Study sites: 42 to 44
    • Primary completion date: Feb 2025 to Jul 2025
    • Study completion date: Aug 2026 to Jan 2027
    v7
  4. Study sites: 34 to 42v6
  5. Study sites: 3 to 34v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 1 to 3v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2023 to May 16, 2023
    v3
  3. Start date: Feb 2023 to Apr 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this clinical phase 3 randomized trial is to compare two different dosing schedules of Docetaxel in combination with ADT and Darolutamide in subjects with mHSPC. The main question aims to compare grade 3-5 adverse events (AEs) in patients with mHSPC treated with 6 cycles of either Docetaxel 75 mg/m2 every 3 weeks in a 3 week cycle or 6 cycles of Docetaxel 50 mg/m2 every 2 weeks in a 4 week cycle in combination with Darolutamide + ADT. The primary endpoint are Grade 3-5 AEs, followed by neutropenia grade 3/4 + grade 5 AEs to be analysed 28 weeks after last patient first Docetaxel dose (LPFD).
Trial Details
NCT Number NCT05676203
Lead Sponsor Jena University Hospital
Collaborators: Bayer
Conditions
(from sponsor)		 Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Related terms Prostatic Neoplasms
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov