The ARASTEP trial is a randomised, double-blind, placebo-controlled Phase 3 study of Darolutamide plus androgen deprivation therapy (ADT), compared with placebo plus ADT, in patients with high-risk biochemical recurrence (BCR) of prostate cancer.
The primary objective of this trial is to determine if Darolutamide plus ADT given for 24 months improves progression free survival by PSMA PET/CT compared with placebo plus ADT given for 24 months.