QoL improvements ID'd in phase 3 ARANOTE trial for mHSPC

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Published: 2 Jun 2025
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Dr Alicia Morgans - Dana-Farber Cancer Institute, Boston, USA

Dr Morgans talks to ecancer about data she presented at ASCO 2025 from the phase 3 ARANOTE trial. 

This evaluated darolutamide plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC). The trial found that darolutamide significantly delayed disease progression and was well tolerated, with fewer treatment discontinuations due to side effects compared to placebo.

Importantly, darolutamide also significantly improved health-related quality of life (HRQoL) outcomes. Patients on darolutamide experienced a 5.1-month delay in deterioration of overall well-being (measured by FACT-P total score) compared to placebo, with improvements noted in social/family well-being, functional well-being, urinary symptoms, and pain. 

Dr Morgans notes that darolutamide is the first androgen receptor inhibitor to show clinically meaningful HRQoL benefits in mHSPC, supporting its use for not only its efficacy but also its positive impact on patients' quality of life.