Tamim Niazi, MDCM, reviews darolutamide data from DASL-HiCaP

In this video, Tamim Niazi, MDCM, discusses findings from the phase 3 DASL-HiCaP trial (NCT04136353), which evaluated the addition of darolutamide (Nubeqa) to androgen deprivation therapy (ADT) and radiation therapy (RT) for patients with very high-risk localized or biochemically persistent/recurrent prostate cancer.¹

The results were presented at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain. Niazi is an associate professor in the department of oncology at McGill University in Montreal, Quebec.

Niazi explains that DASL-HiCaP was designed to address ongoing uncertainty about which patients with very high-risk prostate cancer benefit from treatment intensification beyond standard ADT and RT. Prior studies such as STAMPEDE (NCT00268476) and ENZARAD (NCT02446444) previously demonstrated varying benefits with the addition of androgen receptor pathway inhibitors in certain patient populations, leaving questions about the role of further intensification across this setting. DASL-HiCaP investigated whether adding darolutamide to 2 years of ADT and locoregional RT could improve metastasis-free survival (MFS).

The international, placebo-controlled phase 3 trial enrolled 1106 patients who were randomly assigned to receive darolutamide (600 mg twice daily) or placebo, each in combination with 96 weeks of ADT and RT. The primary end point was MFS based on conventional imaging, including CT and/or technetium bone scans.

At a median follow-up of 3.8 years, the addition of darolutamide significantly improved 4-year MFS compared with placebo (95% vs 88%; HR, 0.42; 95% CI, 0.27 to 0.66; P = .0001). Darolutamide also improved PSA progression-free survival (91% vs 83%; HR, 0.47; 95% CI, 0.33 to 0.67), while reducing the risk of progression to castration-resistant prostate cancer (HR, 0.22) and the need for subsequent hormonal therapy (HR, 0.36). Grade 3 or higher adverse events occurred in 43% of patients receiving darolutamide and 36% receiving placebo. Overall survival data remain immature, and follow-up is ongoing.

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REFERENCE

1. Niazi T, Thomas H, Zhang A, et al. Darolutamide with androgen deprivation therapy (ADT) and definitive or salvage locoregional radiation therapy (RT) for localised, very high-risk prostate cancer: Interim analysis of an international, placebo-controlled, randomised phase 3 trial (DASL-HiCaP; ANZUP1801). Presented at: European Society for Medical Oncology Congress 2026; October 23-27, 2026, Madrid, Spain. Abstract LBA4 https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.esmo/static/esmo2026_abstracts/LBA4.html.pdf