Results from the DASL-HiCaP study were presented on October 24, 2026. DASL-HiCaP (ANZUP1801) – ESMO 2026 Study objective: To evaluate the addition of darolutamide to standard androgen deprivation therapy (ADT) and radiotherapy in patients with very high-risk localized prostate cancer. Phase III: 1,106 patients; randomized, double-blind, placebo-controlled. Treatment: Darolutamide 600 mg twice daily for 96 weeks + ADT and radiotherapy. Control: Placebo + ADT and radiotherapy. Median follow-up: 3.8 years. Primary endpoint: Imaging-based metastasis-free survival (MFS-CI) was significantly improved: HR 0.42 (95% CI 0.27–0.66; p=0.0001). The risk of PSA progression or death was reduced by 53%: HR 0.47 (95% CI 0.33–0.67). Overall survival: The difference was not yet statistically significant: HR 0.88 (95% CI 0.49–1.59). Safety Grade ≥3 adverse events occurred in 43% of patients in the darolutamide group and 36% in the placebo group. Grade ≥2 fatigue/asthenia was reported in 14% and 10% of patients, respectively. Clinical Take-Home Message Darolutamide + ADT + radiotherapy increased 4-year metastasis-free survival from 88% to 95% in patients with very high-risk localized prostate cancer. This represents an absolute improvement of 7 percentage points and a 58% relative reduction in the hazard of metastasis or death. These findings support treatment intensification in this patient population. However, as overall survival data remain immature, an overall survival benefit should not yet be considered established. Link : https://www.bayer.com/media/en-us/darolutamide-plus-adt-and-radiation-therapy-reduces-risk-of-metastasis-or-death-by-58-in-prostate-cancer-patients-at-high-risk-of-recurrence/ #DASLHiCaP #ESMO2026 #ProstateCancer #Darolutamide #UroOncology