DASL-HiCaP Phase III Interim Analysis: Darolutamide Plus Radiotherapy and ADT Cuts Metastasis or Death Risk 58% in High-Risk Localized Prostate Cancer

An interim analysis of the randomized phase III DASL-HiCaP trial, presented at ESMO 2026, showed that darolutamide added to radiotherapy and ADT reduced the risk of metastasis or death by 58% in patients with high-risk localized prostate cancer. The study (NCT04136353, ANZUP1801) enrolled 1106 patients; at a median follow-up of 3.8 years, the 4-year MFS-CI rates were 95% versus 88% (HR=0.42, 95% CI 0.27–0.66, p=0.0001).