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Darolutamide + EBRT is an investigational combination regimen consisting of the androgen receptor antagonist darolutamide and external beam radiation therapy (EBRT). This regimen is being evaluated as an alternative to standard androgen deprivation therapy (ADT) plus EBRT for patients with unfavorable intermediate-risk prostate cancer. Darolutamide is a non-steroidal androgen receptor targeting agent (ARTA) characterized by low blood-brain barrier penetration and a favorable drug-drug interaction profile, which may reduce side effects like fatigue and cognitive impairment compared to traditional ADT. The combination is currently being studied in the Phase II DARIUS trial (NCT05346848) sponsored by Institut Bergonié.
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