Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide
Completed · Phase 2
Conditions studied: Metastatic Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer, Castrate Resistant Prostate Cancer, Hormone Sensitive Prostate Cancer, Non-metastatic Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT04335682
- Run by
- Alliance Foundation Trials, LLC.
- People needed
- 111
- Starts
- 2021-08-17
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2026-06-18
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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