Darolutamide Shows Quality-of-Life Benefits in mHSPC, ARANOTE Trial Finds

As treatment options for metastatic hormone-sensitive prostate cancer (mHSPC) continue to evolve, patient-reported outcomes are playing an increasingly important role in shaping clinical decision-making. Alicia Morgans, MD, MPH, genitourinary medical oncologist and director of the Survivorship Program at Dana-Farber Cancer Center and associate professor of medicine at Harvard Medical School, in a presentation of the study, discusses how the ARANOTE trial (NCT04736199) not only demonstrated clinical efficacy for the combination of androgen deprivation therapy (ADT) and darolutamide, but also highlighted key quality-of-life benefits that could help inform patient and physician conversations.

A core component of the ARANOTE study focused on evaluating health-related quality of life using validated patient-reported outcome tools. Specifically, investigators employed the Brief Pain Inventory short form to measure pain and the Functional Assessment of Cancer Therapy-Prostate (FACT-P) to assess overall well-being. FACT-P captures multiple dimensions of quality of life, including physical, emotional, social/family, and functional well-being, as well as prostate cancer-specific concerns.

In the trial, the combination of ADT and darolutamide was associated with a delayed time to pain progression compared with ADT and placebo. Pain progression was defined as an increase of at least 2 points in a patient’s worst pain score. The hazard ratio for this delay was 0.72, indicating a 28% reduction in the risk of pain worsening with the darolutamide-based regimen.

Beyond pain control, overall quality of life also declined more slowly in patients receiving darolutamide. Time to deterioration in the FACT-P total score, defined as a drop of at least 10 points, was 5.1 months longer in the darolutamide arm compared with placebo.

The trial’s subscale analysis further underscored the impact of treatment on day-to-day functioning. Improvements were most pronounced in social and family well-being, functional well-being, and in the prostate cancer-specific domain, particularly in urinary symptoms. These aspects are especially meaningful for patients managing the emotional and physical toll of a chronic, life-altering disease.

Together, these findings reinforce darolutamide's role not just in disease control, but also in preserving the lived experience of patients, an increasingly vital end point in cancer care.

REFERENCE:

Morgans A, Haresh KP, Jievalta M, et al. Health-related quality of life (HRQoL) outcomes with darolutamide in the phase 3 ARANOTE trial. J Clin Oncol. 2025;43(suppl 16):abstr 5004. doi:10.1200/JCO.2025.43.16_suppl.5004