Triplet Therapy: Darolutamide Plus ADT and Docetaxel Extends Survival in Metastatic Hormone-Sensitive Prostate Cancer by Disease Volume and Risk in ARASENS Trial
The ARASENS Phase 3 trial evaluated the efficacy of darolutamide (Nubeqa) in combination with androgen deprivation therapy (ADT) and docetaxel in metastatic hormone-sensitive prostate cancer (mHSPC) across different patient subgroups based on disease volume and risk. Results showed a median overall survival (OS) of 42.4 months in the high-volume placebo group, while median OS was not reached in the darolutamide arm across subgroups, suggesting substantial survival extension. For radiographic progression-free survival (rPFS), darolutamide significantly delayed progression with median rPFS of 43.7 months in high-volume patients compared to 19.1 months in the control group, indicating a 2-fold improvement.
Safety profiles were comparable, with similar adverse events across all groups, supporting darolutamide as a promising intensification option for high-risk or high-volume mHSPC.