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Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide
Sponsor: Alliance Foundation Trials, LLC.
Summary
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.
Official title: A Randomized Phase II Study of Androgen Receptor Directed Therapy on COGnitive Function in Patients Treated With Darolutamide or Enzalutamide (ARACOG)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
111
Start Date
2021-08-17
Completion Date
2026-08
Last Updated
2025-11-04
Healthy Volunteers
No
Conditions
Interventions
Darolutamide
Patients randomized to darolutamide.
Enzalutamide
Patients randomized to enzalutamide.
Locations (8)
University of California - San Francisco at Mount Zion
San Francisco, California, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
University of Kansas Cancer Center
Fairway, Kansas, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States