Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer.
Matthew R SmithMaha HussainFred SaadKarim FizaziCora N SternbergE David CrawfordEvgeny KopyltsovChandler H ParkBoris AlekseevÁlvaro Montesa-PinoDingwei YeFrancis ParnisFelipe José Silva Melo CruzTeuvo L J TammelaHiroyoshi SuzukiTapio UtriainenCheng FuMotohide UemuraMaría J Méndez-VidalBenjamin L MaughanHeikki JoensuuSilke ThieleRui LiIris KussBertrand Tombalnull nullPublished in: The New England journal of medicine (2022)
In this trial involving patients with metastatic, hormone-sensitive prostate cancer, overall survival was significantly longer with the combination of darolutamide, androgen-deprivation therapy, and docetaxel than with placebo plus androgen-deprivation therapy and docetaxel, and the addition of darolutamide led to improvement in key secondary end points. The frequency of adverse events was similar in the two groups. (Funded by Bayer and Orion Pharma; ARASENS ClinicalTrials.gov number, NCT02799602.).