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A major phase 3 trial shows adding darolutamide to standard hormone therapy and radiation dramatically reduced the risk of metastasis in very high-risk localized prostate cancer. At 4 years, the metastasis-free survival rate reached 95% with darolutamide vs. 88% with placebo — cutting the risk of metastasis or death by 58%. Researchers say this could redefine the standard of care for this patient group.
A phase 3 trial called DASL-HiCaP has delivered a striking win for patients with very high-risk localized prostate cancer. Adding darolutamide (Nubeqa) to androgen deprivation therapy (ADT) and radiation therapy (RT) slashed the risk of metastasis or death by 58% compared to placebo, with results presented at the 2026 ESMO Congress. Researchers say the findings could establish a new standard of care for this difficult-to-treat population.
The trial enrolled 1,106 patients who were randomized to receive darolutamide or placebo for 96 weeks alongside ADT and radiation targeting the prostate (or prostate bed) and pelvic lymph nodes. Benefits were consistent across key subgroups — including patients with or without pelvic nodal involvement and those receiving primary or salvage RT. No new safety signals emerged, and side effect rates were broadly similar between arms.
By the Numbers:
Why it matters: Very high-risk localized prostate cancer carries a significant chance of recurrence even after aggressive local treatment. This trial demonstrates that adding an androgen receptor inhibitor to the standard regimen can meaningfully delay — and potentially prevent — metastatic progression, offering patients a better shot at long-term disease control.
