The addition of darolutamide to standard therapy significantly improves overall survival in men with metastatic, hormone-sensitive prostate cancer, a large international study shows.

Time to developing castration-resistant disease was also much longer among patients given the potent androgen receptor inhibitor versus placebo, according to the researchers.

Given the absence of any major safety signal, investigators in the multicentre phase 3 trial to evaluate the combination said their results supported the use of darolutamide (also known as ODM-201) with androgen-deprivation therapy (ADT) and docetaxel in this clinical setting.

In the ARASENS (ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer) trial, Harvard Medical School-led doctors assigned 1300 men with metastatic, hormone-sensitive prostate cancer to receive oral darolutamide (300mg twice daily) or matching placebo in addition to standard treatment.