Darolutamide is an antiandrogen medication used in the treatment of non-metastatic castration-resistant prostate cancer in men. However, the safety and efficacy of the drug have been controversial. This study aims to investigate the overall survival in patients with non-metastatic castration-resistant prostate cancer associated with the use of darolutamide.
This randomized, placebo-controlled, double-blind trial included a total of 1,509 men with non-metastatic castration-resistant prostate cancer. The patients were randomly assigned in a 2:1 ratio to receive darolutamide (955 patients) or placebo (554 patients), in addition to the standard androgen-deprivation therapy. The primary outcome of the study was overall survival, along with time to the first symptomatic event and adverse events.
During the median follow-up of 29.0 months, the overall survival at three years was 83% in the darolutamide group and 77% in the placebo group. The risk of death was 31% lower in the darolutamide group when compared with the placebo group. Treatment with darolutamide was also associated with increased time to the first symptomatic skeletal event and cytotoxic therapy. The risk of adverse events was similar in the two groups.
The research concluded that darolutamide was associated with increased overall survival, time to the first symptomatic skeletal event, and time to cytotoxic therapy in patients with non-metastatic castration-resistant prostate cancer.