Pain and health-related quality-of-life outcomes with darolutamide in metastatic hormone-sensitive prostate cancer (ARANOTE): secondary and exploratory analyses of a multicentre, randomised, placebo-controlled, phase 3 trial

Secondary and exploratory analyses from the phase 3 ARANOTE trial demonstrate that darolutamide combined with androgen deprivation therapy (ADT) provides clinically meaningful delays in pain progression and time to deterioration of overall wellbeing in patients with metastatic hormone-sensitive prostate cancer (mHSPC). These patient-reported outcome data complement the previously established survival benefits of the regimen. The findings strengthen the evidence base supporting darolutamide plus ADT as a standard-of-care treatment option for mHSPC. The study was published in The Lancet Oncology in April 2026.