Pain and health-related quality-of-life outcomes with darolutamide in mHSPC: secondary outcomes of the multinational phase 3 ARANOTE trial

The phase 3 ARANOTE trial, at 133 centers in 15 countries, showed that darolutamide (600 mg twice daily) significantly improved radiological progression-free survival versus placebo in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Pain, HRQoL, and safety outcomes of ARANOTE have now been published. Patients were randomized 2:1 to darolutamide (n=446) or placebo (n=223), both with investigator’s choice of ADT starting within 12 weeks before randomization. Investigators and participants remained masked to treatment assignment throughout the study. Median follow-up was 22.8 months in the darolutamide group and 20.3 months in the placebo group. Darolutamide delayed time to pain progression (HR 0.72; 95% 0.54-0.96) and extended time to deterioration in FACT-P total score (0.76; 0.61-0.94) versus placebo. The most common grade 3-4 adverse events were hypertension (4% with darolutamide versus 4% with placebo), anemia (3% versus 4%), and aspartate aminotransferase increase (2% versus one patient). Serious adverse events occurred in 24% of patients in each arm. One treatment-related grade 5 event occurred. The authors conclude that these data support consideration of darolutamide plus ADT as a standard-of-care treatment option for mHSPC.