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A new treatment combo is changing the game for high-risk prostate cancer. The phase 3 DASL-HiCaP trial found that adding darolutamide to androgen deprivation therapy (ADT) and radiation therapy (RT) slashed the risk of metastasis by 58% in men with very high-risk localized prostate cancer. Researchers say the results define a new standard of care for this patient group.
A new treatment combo is changing the game for high-risk prostate cancer. The phase 3 DASL-HiCaP trial — presented at the 2026 ESMO Congress in Madrid — found that adding darolutamide (Nubeqa) to androgen deprivation therapy (ADT) and radiation therapy (RT) significantly reduced the risk of metastasis in men with very high-risk localized prostate cancer. Lead investigator Dr. Tamim Niazi of McGill University called the results a "new paradigm" for curative-intent treatment in this population.
The trial enrolled 1,106 patients randomized to receive standard RT and long-course ADT with or without darolutamide for 96 weeks. The benefit was consistent across subgroups, including patients with and without pelvic nodal involvement, and no new safety signals emerged.
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Why it matters: These results offer a meaningful step forward for a patient group with limited options, potentially redefining the standard of care. However, experts note that overall survival data remain immature, and questions linger about how to best define "very high risk" in the era of modern imaging and biomarkers.
