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Sandy Srinivas, MD


Adding Darolutamide to Standard Treatment in Metastatic, Hormone-Sensitive Prostate Cancer

By: Celeste L. Dixon
Posted: Tuesday, August 30, 2022

Using darolutamide in combination with androgen-deprivation therapy and docetaxel in patients with metastatic, hormone-sensitive prostate cancer is a strategy supported by the results of the international phase III ARASENS trial of 1,306 patients published in The New England Journal of Medicine. Versus placebo, darolutamide in combination with the standard treatment increased overall survival—the primary endpoint—with no concomitant increase in adverse events, reported Matthew R. Smith, MD, PhD, of Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, and colleagues. Key secondary endpoints also favored the androgen receptor inhibitor. Darolutamide has already been linked to improved overall survival in patients with nonmetastatic, castration-resistant prostate cancer.

In ARASENS, patients—more than 86% of whom had metastatic disease—received placebo (n = 655) or a 600-mg daily dose of darolutamide (n = 651) in the combination treatment. The primary analysis results revealed a 32.5% lower risk of death in those taking darolutamide (P < .001). “This survival benefit was observed despite a high percentage of patients who received subsequent life-prolonging systemic therapy in the placebo group,” noted Dr. Smith and co-investigators. In both arms, most patients (78.2%) had a Gleason score of at least 8.

Further, “darolutamide was associated with significantly greater benefits than placebo for the first five secondary efficacy endpoints tested hierarchically,” continued the team. In the darolutamide cohort, the times to development of both castration-resistant disease and pain progression were significantly longer (P < .001 and P = .01, respectively). The times to a first symptomatic skeletal event and to initiation of subsequent systemic antineoplastic therapy were significantly longer, too (P = .02 and P < .001, respectively), and symptomatic skeletal event–free survival favored the darolutamide group (P < .001). Finally, grade 3 or 4 adverse events occurred with a similar frequency in both arms (66.1% vs. 63.5% in the darolutamide and placebo arms, respectively).

Disclosure: The study authors’ disclosure information can be found at

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