Subgroup Analysis of The ARASENS Trial

The ARASENS trial, a large phase 3 study, investigated the impact of adding darolutamide, a novel androgen receptor inhibitor, to the standard treatment of androgen-deprivation therapy (ADT) and docetaxel chemotherapy in patients with metastatic hormone-sensitive prostate cancer (mHSPC). A recent subgroup analysis focused on whether the benefits of this combination extend across age groups.

In this analysis, patients were divided into those younger than 75 years and those 75 or older. Both groups had high rates of comorbidities and were on numerous medications, reflecting the complexity of treating older patients. Darolutamide significantly improved overall survival in both age categories compared to placebo. For patients under 75, the risk of death was reduced by 30%, while those 75 or older experienced a 39% reduction. Similarly, darolutamide markedly delayed the progression to castration-resistant prostate cancer and postponed the need to start new therapies. These improvements translated into substantial gains in months lived without disease progression; for instance, median times to progression were more than doubled in treated patients, extending from about 19 months without darolutamide to over 40 months with the drug.

Importantly, the safety profile of the darolutamide combination was consistent across ages. While older patients experienced slightly more treatment-emergent adverse events, the overall tolerability was favorable and comparable to younger patients. This suggests that age and common comorbidities should not exclude patients from receiving this effective triplet therapy. The findings underscore that darolutamide plus ADT and docetaxel should be considered a standard of care approach for metastatic hormone-sensitive prostate cancer, delivering meaningful survival benefits without substantial added risk, even in older populations.

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