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About The ARANOTE Study

Randomized, double-blind, placebo-controlled multicenter phase III study (including 2 Canadian sites)

ARANOTE Study Design

Adapted from NUBEQA® Product Monograph

  • Median age: 70 years (range 43-93)
  • Primary endpoint: radiographic Progression Free Survival (rPFS)
  • Secondary endpoints include:
    • Overall survival (OS), time to initiation of subsequent antineoplastic therapy, time to CRPC, time to pain progression

Primary Endpoint: Radiographic Progression-Free Survival

ARANOTE Primary Endpoint

Adapted from NUBEQA® Product Monograph

  • NUBEQA® + ADT
    significantly improved rPFS
    vs. placebo + ADT
  • HR (95% CI):* 0.541 (0.413, 0.707), p<0.0001
  • Number (%) of events was 128/446 (28.7%) for NUBEQA + ADT and 94/223 (42.2%) for placebo + ADT

 

32.5% of patients in the NUBEQA® + ADT arm and 42.5% of patients in the placebo + ADT arm received subsequent life-prolonging therapy.


    • 1
      NUBEQA® Product Monograph, Bayer Inc., August 18, 2025.
    • 2
      Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE)
    • 3
      Saad F, Vjaters E, Shore N, Olmos D, Xing N, Pereira de Santana Gomes AJ, et al. Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial. J Clin Oncol. 2024;42(36):4271-81.