NCT04335682CompletedPhase 2
Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide
A Randomized Phase II Study of Androgen Receptor Directed Therapy on COGnitive Function in Patients Treated With Darolutamide or Enzalutamide (ARACOG)
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 111 (actual)
- First submitted
- 13 Jan 2020
- Start date
- 17 Aug 2021
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- Alliance Foundation Trials, LLC.
- Diseases
- Prostate cancer
- NCT number
- NCT04335682
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 111
- From 17 Aug 2021 to the primary completion date, 1 Sept 2025
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Progressive disease per PCWG3 criteria with EITHER: Metastatic CRPC or non- metastatic CRPC (M0CRPC)
- For mCRPC: metastatic disease documented by standard or novel imaging techniques
- OR for M0CPRC: no evidence of metastatic disease on standard imaging.
- OR mHSPC
- Surgically or medically castrated, with testosterone levels of \<50 ng/dL. If the patient is medically castrated, continuous dosing with GnRH agonist or antagonist must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Able to complete cognitive testing and patient reported outcome surveys in English.
- Ability to swallow study medications whole.
- Able to provide informed consent.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Northwestern University Feinberg School of Medicine Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Kansas Cancer Center Coordinator of this site? Confirm its status | Fairway | United States | Unknown status |
| Froedtert and the Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| University of Oklahoma Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| University of California - San Francisco at Mount Zion Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.