Dr Morgans on the Influence of HRQOL Data on the Use of Darolutamide Plus ADT in mHSPC

"From a clinical perspective, this [QOL analysis] gives data [to support] the decisions that clinicians have already been [making], which is dropping the chemotherapy and giving this doublet combination…when they find that the patient cannot handle chemotherapy. We now have the evidence to show that we can maintain cancer control and maintain QOL when we do that."

Alicia Morgans, MD, MPH, a genitourinary medical oncologist and medical director of the Survivorship Program at Dana-Farber Cancer Institute, as well as an associate professor of medicine at Harvard Medical School, discusses how patient-reported outcome (PRO) data from an analysis of from the phase 3 ARANOTE trial (NCT04736199) could help guide the use of darolutamide (Nubeqa) plus androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC).

At the 2025 ASCO Annual Meeting, updated PRO analyses from ARANOTE demonstrated that patients who received darolutamide plus ADT experienced improvements in health-related quality of life (HRQOL) vs those treated with ADT plus placebo. Specifically, the combination was associated with a delay in time to pain progression (stratified HR, 0.72; 95% CI, 0.54-0.96) and prolonged time to deterioration in the Functional Assessment of Cancer Therapy–Prostate (FACT-P) total score (HR, 0.76; 95% CI, 0.61-0.94). These findings complement previously reported efficacy data, positioning the combination as a non-chemotherapy doublet option for this population.

Morgans noted that these data are particularly relevant for clinicians who seek to balance oncologic efficacy with tolerability, especially in patients who may not be ideal candidates for triplet regimens that include chemotherapy. The addition of darolutamide to ADT—without chemotherapy—represents an effective strategy that can preserve HRQOL while maintaining cancer control, she emphasized. Although prior studies have established the benefit of doublet therapy with ADT plus androgen receptor pathway inhibitors in mHSPC, ARANOTE is the first to demonstrate this benefit for ADT plus darolutamide without chemotherapy, Morgans noted.

This PRO analysis supports the clinical decision-making process already taking place in practice, particularly in situations where patients may be unable to tolerate more intensive regimens, she added. With this new evidence, clinicians can feel more confident in selecting darolutamide plus ADT as a frontline therapy that offers both disease control and sustained quality of life in appropriately selected patients, Morgans concluded.