Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide

Study acronym: ARACOG
StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Results posted: Sep 21, 2026 Show 4 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 5 of 10 entries
    • Publications: details revised at 12 of 12 entries
    • Study description shortened, about 2 words
  2. Secondary endpoints revised (10)
    • Primary endpoint revised
    v18
  3. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Aug 2026 to May 1, 2026
    v17
  4. Primary completion date changed from estimate of Oct 1, 2025 to Sep 1, 2025v16
  5. Re-verified, no change to tracked fieldsv15
Show 13 earlier versionsHide 13 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 132 to confirmed 111
    • Study sites: 9 to 8
    v14
  2. Primary completion date: Aug 1, 2025 to Oct 1, 2025v13
  3. Re-verified, no change to tracked fieldsv12
  4. Primary completion date: Aug 1, 2024 to Aug 1, 2025v11 Show 5 more changesShow less
    • Study completion date: Aug 2024 to Aug 2026
    • Eligibility criteria shortened, about 233 words
    • Secondary endpoints: details revised at 5 of 10 entries
    • Study description shortened, about 7 words
    • Site details revised at 4 of 9 sites
  5. Study sites: 12 to 9v10
  6. Primary completion date: Aug 2023 to Aug 1, 2024v9
  7. Site details revised at 6 of 12 sitesv8
  8. Trial status: Not Yet Recruiting to Recruitingv7 Show 4 more changesShow less
    • Start date changed from estimate of Apr 2021 to Aug 17, 2021
    • Study sites: 2 to 12
    • Primary completion date: Apr 2023 to Aug 2023
    • Study completion date: Apr 2024 to Aug 2024
  9. Primary completion date: Mar 2023 to Apr 2023
    • Study completion date: Mar 2024 to Apr 2024
    • Start date: Mar 2021 to Apr 2021
    v6
  10. Re-verified, no change to tracked fieldsv5
  11. Start date: Sep 2020 to Mar 2021
    • Primary completion date: Sep 2022 to Mar 2023
    • Study completion date: Sep 2023 to Mar 2024
    v4
  12. Primary completion date: Aug 2022 to Sep 2022
    • Study completion date: Aug 2023 to Sep 2023
    • Start date: Aug 2020 to Sep 2020
    v3
  13. Start date: May 2020 to Aug 2020
    • Primary completion date: May 2022 to Aug 2022
    • Study completion date: May 2023 to Aug 2023
    v2
  1. Study First Submitted
  • 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.
This is a prospective, randomized, open-label phase II study comparing cognitive outcomes between men with metastatic and non-metastatic castration resistant prostate cancer (CRPC) or metastatic hormone sensitive prostate cancer (HSPC). Approximately 132 patients will be enrolled. Eligible patients will be randomized in a 1:1 fashion to treatment with enzalutamide 160 mg orally daily or darolutamide 600 mg orally twice daily, in combination with standard LHRH agonist based treatment. Cognitive assessments will be performed using modules from Cambridge Neuropsychological Test Automated Battery (CANTAB) an internationally recognized software for assessing cognitive function and impairment.
Trial Details
NCT Number NCT04335682
Lead Sponsor Alliance Foundation Trials, LLC.
Collaborators: Bayer
Conditions
(from sponsor)		 Metastatic Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer, Castrate Resistant Prostate Cancer, Hormone Sensitive Prostate Cancer, Non-metastatic Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 111 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov