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Darolutamide Plus ADT Improves Outcomes in Metastatic Hormone-Sensitive Prostate Cancer


Key Clinical Summary: 

  • Design/Population: The phase 3 ARANOTE trial evaluated darolutamide plus ADT versus ADT alone in patients with metastatic hormone-sensitive prostate cancer.
  • Key Outcomes: Darolutamide plus ADT significantly improved radiographic progression-free survival, increased rates of undetectable PSA, and demonstrated a favorable tolerability profile with low discontinuation rates.
  • Clinical Relevance: These data support darolutamide plus ADT as an effective chemotherapy-sparing treatment option in metastatic hormone-sensitive prostate cancer, expanding frontline therapy strategies.

Kirollos Hanna, PharmD, Mayo Clinic, Rochester, Minnesota, discusses results from the phase 3 ARANOTE trial evaluating darolutamide plus androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer. 

The combination significantly improved radiographic progression-free survival and disease control compared with ADT alone, with a favorable safety profile, and supports the role of darolutamide plus ADT as an effective doublet option without the need for chemotherapy.

Dr Hanna presented these results at the Hematology/Oncology Pharmacy Association (HOPA) Annual Meeting in New Orleans, Louisiana. 


Source: 

Hanna K. Prostate-specific antigen response with darolutamide plus androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer in ARANOTE. Presented at HOPA Annual Conference. March 25-27, 2026. CR13.

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