Prof Tamim Niazi speaks to ecancer about the interim analysis of the phase III DASL-HiCaP trial, which evaluated darolutamide added to androgen deprivation therapy (ADT) and definitive or salvage locoregional radiotherapy in patients with very high-risk localised prostate cancer or biochemical persistence or recurrence within one year of radical prostatectomy.

The trial randomised 1,106 patients to receive darolutamide or placebo alongside ADT and radiotherapy.

After a median follow-up of 3.8 years, darolutamide significantly improved metastasis-free survival assessed by conventional imaging.

At four years, 95% of patients receiving darolutamide remained metastasis-free, compared with 88% in the placebo group, representing a 58% reduction in the risk of metastasis or death.

These findings support adding darolutamide to ADT and locoregional radiotherapy to improve metastasis-free survival in patients with very high-risk localised or biochemically persistent or recurrent prostate cancer.

Follow-up is ongoing to assess whether these benefits translate into improved overall survival.