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ARACOG: A Randomized Phase II Study of Androgen Receptor Directed Therapy on COGnitive Function in Patients Treated with Darolutamide or Enzalutamide
Recruiting
To compare the effects of treatment with enzalutamide (ENZ) versus darolutamide (DARO) on the cognitive function of men with non-metastatic and metastatic castration-resistant prostate cancer (mCRPC) by comparing the change in the maximally changed cognitive domain from baseline in patients in each study arm by 24 weeks.
Male
18 years and over
Inclusion Criteria:
• confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
• castration-resistant prostate cancer defined as 3 PSA rises at least 1 week apart, with the last PSA >2 ng/mL, while on treatment
• testosterone level of <50 ng/dL
• able to walk and care for self, but unable to work
• able to read & speak English
• able to swallow study tablets whole
Exclusion Criteria:
• prior chemotherapy for treatment of CRPC. Men who received chemotherapy for castrate-sensitive prostate cancer are eligible provided chemotherapy was completed more than 6 months ago
• prior treatment with specific drugs (study staff will review)
• radiation treatment for more than 21 days during enrollment in the study
• neurological diseases that affect thinking (dementia, seizures, etc.)
• chronic use of opiates that affects thinking
• significant history of falls or risk of falls
Drug: Darolutamide, Drug: Enzalutamide
Cancer
Clinics and Surgery Center (CSC), Castration Resistant Prostate Cancer, CRPC, Metastatic Prostate Cancer, Prostate Cancer, Prostate Cancer
Stuart Bloom - stubloom@umn.edu
Stuart Bloom
Phase 2
SITE00000986
See this study on ClinicalTrials.gov