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Dr Morgans on HRQOL Outcomes With Darolutamide Plus ADT in mHSPC

Alicia Morgans, MD, MPH, discusses health-related quality of life outcomes with darolutamide plus ADT in patients with mHSPC.

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    "Importantly, this combination shows both efficacy in terms of cancer control, but also this maintenance or improvement in QOL that is important for patients. When we get to that ultralow or low PSA, we’re getting better cancer control and probably maintaining [that control] for longer and helping to keep that QOL in a better place."

    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 findings from an analysis of patient-reported outcomes (PROs) from the phase 3 ARANOTE trial (NCT04736199), which evaluated the addition of darolutamide (Nubeqa) to androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC).

    Data from this analysis were presented at the 2025 ASCO Annual Meeting, and showed that patients receiving darolutamide plus ADT experienced improvements in health-related quality of life (HRQOL) compared with those receiving ADT plus placebo, Morgans stated. Specifically, the addition of darolutamide delayed time to pain progression (stratified HR, 0.72; 95% CI, 0.54-0.96) and extended median time to deterioration on the Functional Assessment of Cancer Therapy-Prostate (FACT-P) instrument (HR, 0.76; 95% CI, 0.61-0.94), Morgans reported.

    This predefined QOL analysis, embedded within the ARANOTE trial, incorporated patient responses from the Brief Pain Inventory–Short Form and FACT-P questionnaire to assess subjective experiences of symptom burden and well-being, she noted. The analysis demonstrated that darolutamide plus ADT is the only androgen receptor pathway inhibitor to show statistically significant improvements in QOL outcomes compared with control in this disease setting, Morgans explained. The median duration of improved QOL was extended by 5.1 months with the addition of darolutamide, she added.

    Further exploratory analysis assessed whether the depth of prostate-specific antigen (PSA) response correlated with QOL, Morgans continued. Patients who achieved a PSA of at least 0.2 ng/mL experienced more favorable QOL outcomes, suggesting that biochemical response and HRQOL are closely linked, she stated. These findings underscore that achieving deeper responses may not only improve oncologic outcomes but also enhance patients’ day-to-day well-being, Morgans said.

    Together, these data support the addition of darolutamide to ADT in mHSPC for not only its survival benefits, but also for its potential to preserve and improve patient-reported QOL outcomes, she concluded.


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