Alicia Morgans, MD, on QOL outcomes with darolutamide plus ADT in mHSPC

The phase 3 ARANOTE trial (NCT04736199) showed that the addition of darolutamide (Nubeqa) to androgen deprivation therapy (ADT) extended radiographic progression-free survival (rPFS) compared with ADT alone in patients with metastatic hormone-sensitive prostate cancer (mHSPC).¹ Findings from this trial recently led to the FDA approval of darolutamide plus ADT in this indication.

Data presented at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois further supported the benefits of this combination, showing that darolutamide plus ADT was associated with positive quality of life outcomes compared with ADT alone.² In an interview with Urology Times®, Alicia K. Morgans, MD, MPH, walked through key efficacy and QOL data from the ARANOTE trial, touching on the implications of these findings for patients and urologists.

Morgans noted, “As we are striving to ensure that patients get treatment combinations that will optimize their cancer control outcomes, also finding options that help them feel well during that process is really critical, certainly to patients and also to the clinicians that take care of them.”

Morgans is a genitourinary medical oncologist and associate professor of medicine at Harvard Medical School as well as the director of the survivorship program at Dana-Farber Cancer Institute in Boston, Massachusetts.

Overall, data showed that darolutamide extended the time to deterioration in FACT-P total score (overall well-being). The median time to deterioration was 16.6 months in the darolutamide arm vs 11.5 months in the placebo arm (HR, 0.76; 95% CI 0.61 to 0.93).

This extension in the darolutamide arm was primarily driven by improvements in the subscales of social/family well-being (HR, 0.79; 95% CI 0.64 to 0.98), functional well-being (HR, 0.78; 95% CI, 0.63 to 0.96), and urinary symptoms (HR, 0.78; 95% CI, 0.61 to 0.99).

“This study gives important additional data that ADT and darolutamide can not only control patients cancer, but also can be associated with a tolerable side effect profile, and actually can maintain patients in terms of how well they feel and they function when compared to other things like ADT alone,” Morgans concluded. “This, I think, is a really reasonable and good option for patients with metastatic hormone sensitive prostate cancer.”

REFERENCE

1. Saad F, Vjaters E, Shore N, et al. Darolutamide in combination with androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer from the phase III ARANOTE trial. J Clin Oncol. 2024 Sep 16:JCO2401798. doi:10.1200/JCO-24-01798

2. Morgans A, Haresh KP, Jievaltas M, et al. Health-related quality of life (HRQoL) outcomes with darolutamide in the phase 3 ARANOTE trial. J Clin Oncol. 2025;43(suppl 17):5004. doi:10.1200/JCO.2025.43.16_suppl.5004