Phase 3 DASL-HiCaP: Darolutamide Reduces Metastasis Risk in High-Risk Prostate Cancer

The phase 3 DASL-HiCaP trial, presented at ESMO 2026, has demonstrated improved metastasis-free survival with the addition of darolutamide to androgen deprivation therapy (ADT) and radiotherapy in patients with localised or locally advanced prostate cancer at high risk of recurrence.

The randomised, placebo-controlled study enrolled 1,106 patients, who received darolutamide or placebo alongside ADT and radiotherapy for approximately two years. After a median follow-up of 3.8 years, darolutamide reduced the risk of metastasis or death by 58% (HR 0.42).

At four years, metastasis-free survival was 95% with darolutamide versus 88% with placebo. PSA progression-free survival also improved, reaching 91% versus 83% at four years (HR 0.47).

Grade 3 or higher adverse events occurred in 43% of patients receiving darolutamide and 36% receiving placebo. Four-year overall survival was 97% versus 95%, but the available data do not yet establish a statistically significant survival advantage.

These findings extend the evidence for darolutamide into an earlier, non-metastatic disease setting.

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