Darolutamide Boosts Patient Well-Being in Prostate Cancer

In an interview with Targeted Oncology^TM, Alicia Morgans, MD, MPH, genitourinary medical oncologist at Dana-Farber Cancer Center in Boston, Massachusetts, discusses a quality-of-life assessment of the phase 3 ARANOTE study (NCT04736199) presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

The analysis found that arolutamide (Nubeqa) plus androgen deprivation therapy (ADT) demonstrated positive impacts on health-related quality of life in patients with metastatic hormone-sensitive prostate cancer (mHSPC), including clinically meaningful delays in pain progression, when compared with placebo and ADT.

“[This] is the first and only androgen receptor antagonist to demonstrate clinically meaningful delays in pain progression and overall well-being, including those specific areas of social and family well-being, functional well-being, and urinary symptoms. Health-related quality of life benefits may be greatest in patients treated with darolutamide who had ultralow [prostate-specific antigen (PSA)] levels,” said Morgans, who is also an associate professor of medicine at Harvard Medical School, in a presentation of the study.

When oncologists and urologists make clinical decisions, Morgans explains in the interview, their priority is to choose treatments that effectively control cancer while being tolerable for patients. The combination of ADT and darolutamide offers both strong cancer control and an improved quality of life for patients, particularly in maintaining pain control compared to ADT and placebo.

"We already know that doublet therapies combining ADT with androgen receptor pathway inhibitors are crucial for this patient population. This study is the first to demonstrate that ADT and darolutamide without chemotherapy is a viable option, and it provides evidence that this doublet is more effective than ADT alone—data we previously lacked," Morgans says.

From a clinical standpoint, this research supports the real-world decisions clinicians have already been making: opting for this doublet combination without chemotherapy when patients cannot tolerate it.

"Now, we have the evidence to show that this approach can maintain both cancer control and quality of life," Morgans concludes.