• The ARANOTE trial demonstrated that darolutamide plus androgen deprivation therapy (ADT) significantly improves radiographic progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
• Darolutamide-treated patients experienced a 46% reduction in the risk of radiographic progression or death compared to those receiving ADT plus placebo, with consistent benefits across subgroups.
• The combination therapy also delayed time to castration-resistant prostate cancer and pain progression, while showing a favorable safety profile with lower rates of fatigue.
• These findings suggest darolutamide plus ADT could become a new standard of care for mHSPC, offering an alternative to chemotherapy-based regimens.