A groundbreaking study presented at the 2025 Genitourinary Cancers Symposium revealed that the combination of darolutamide (Nubeqa) and standard therapies significantly reduces the risk of death in patients with metastatic hormone-sensitive prostate cancer (mHSPC), irrespective of age. This new analysis marks a noteworthy advancement in prostate cancer treatment, offering hope to patients and enhancing provider and patient treatment options in the USA.

The findings come from the phase 3 ARASENS trial, which initially showed a 32.5% reduction in the risk of death for patients treated with darolutamide, androgen deprivation therapy (ADT), and docetaxel, compared to placebo plus ADT and docetaxel. Durability of these improvements has been highlighted in post hoc analyses.

In the study, researchers sought to evaluate the efficacy and safety of darolutamide in age cohorts within the trial. “Age subgroups were analyzed for baseline characteristics including ongoing comorbidities, treatment duration, completion of [darolutamide plus ADT and docetaxel] therapy, use of first subsequent therapy, key efficacy outcomes, and safety,” said Joan Carles, MD, PhD, from Vall d’Hebron Institute of Oncology.

The ARASENS trial included 1,305 patients, aged 41 to 89, with 1,086 patients younger than 75 (83% of the total) and 219 patients 75 or older (17% of the total). Both age groups showed similar baseline characteristics, enhancing the reliability of the data.

Results revealed that the efficacy benefits of darolutamide, including overall survival (OS) and time to metastatic castration-resistant prostate cancer (mCRPC), were consistent across both age groups. The hazard ratio (HR) for OS was 0.70 in the younger age group and 0.61 in the older group. This indicates that darolutamide not only improves survival but also extends the time before patients need subsequent therapy.

Carles reported, “The duration of the study treatment was consistently longer with darolutamide compared with placebo, and most patients completed the full 6 cycles…regardless of age. Darolutamide plus ADT and docetaxel consistently demonstrated improved outcomes compared to placebo, including overall survival, time to mCRPC, and time to initiation of subsequent antineoplastic therapy, all of which are critical factors in patient health and quality of life.”

Looking beyond the numbers, the study emphasized that the improved outcomes of darolutamide therapy were achieved even when a higher percentage of patients in the placebo group received subsequent life-prolonging treatments. Key enablers included: “Abiraterone [Zytiga] was the most frequently used subsequent therapy in both age subgroups, consistent with the overall population. Use of docetaxel or cabazitaxel [Jevtana] as first subsequent therapy was less frequent in older patients than younger patients.

The very good safety profiles across the board included similar incidences and severity of treatment-emergent adverse events (TEAEs) between the darolutamide and placebo groups. Though, slightly higher incidence of grade 3/4 TEAEs, including neutropenia and anemia, were observed.

By presenting data on darolutamide plus ADT and docetaxel improving overall survival, time to mCRPC, and time to initiation of subsequent therapy in both younger and older patients, this analysis validates the potential of these treatments for all age groups,” Carles concluded.

In Also to be considered:, patients with metastatic hormone-sensitive prostate cancer benefited from treatment with darolutamide plus ADT and docetaxel regardless of age, with improvements in overall survival, time to metastatic castration-resistant prostate cancer, and time to initiation of subsequent therapy compared with placebo.