Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide
Status:
Recruiting
Trial end date:
2024-08-01
Target enrollment:
Participant gender:
Summary
This is a prospective, randomized, open-label phase II study comparing cognitive outcomes
between men with non-metastatic and metastatic castration-resistant prostate cancer (mCRPC or
M0CRPC) treated with darolutamide or enzalutamide. 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.