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ARANOTE

Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial

Phase 3N = 669NCT04736199

Population
Men with metastatic hormone-sensitive prostate cancer
Design
Global phase 3 trial, 2:1 randomization to darolutamide 600 mg twice daily or placebo with concomitant ADT, without chemotherapy; randomization March 2021 to August 2022. Primary end point radiological progression-free survival.
Primary endpoint
rPFS
Arms
  • Placebo plus ADT (control, n = 223): Placebo plus ADT
  • Darolutamide plus ADT (experimental, n = 446): Darolutamide 600 mg twice daily plus ADT
People
Saad F, ARANOTE
rPFSHR 0.54 (95% CI 0.41–0.71)OSHR 0.81 (95% CI 0.59–1.12)
Show the numbers
Results reported for ARANOTE
EndpointAnalysisDarolutamide plus ADTPlacebo plus ADTEffect
rPFSRandomized patients (analysis population not stated in the abstract)primarySaad 2024——HR 0.54 (95% CI 0.41–0.71)P<0.0001The abstract describes this as a 46% reduction in the risk of radiological progression or death; benefits were consistent across subgroups including high- and low-volume disease.
OSRandomized patients (analysis population not stated in the abstract)interimSaad 2024——HR 0.81 (95% CI 0.59–1.12)The abstract calls the overall survival results suggestive of benefit; the confidence interval includes 1 and no p value is given. The full-text methods describe this as an interim analysis of OS conducted at the time of the primary rPFS analysis.
Results reported for ARANOTE
EndpointAnalysisDarolutamide plus ADTPlacebo plus ADTEffect
rPFSRandomized patients (analysis population not stated in the abstract)primarySaad 2024——HR 0.54 (95% CI 0.41–0.71)P<0.0001The abstract describes this as a 46% reduction in the risk of radiological progression or death; benefits were consistent across subgroups including high- and low-volume disease.
OSRandomized patients (analysis population not stated in the abstract)interimSaad 2024——HR 0.81 (95% CI 0.59–1.12)The abstract calls the overall survival results suggestive of benefit; the confidence interval includes 1 and no p value is given. The full-text methods describe this as an interim analysis of OS conducted at the time of the primary rPFS analysis.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
rPFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
rPFS0.540.41–0.71
OS0.810.59–1.12
Primary publication: 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):4271-4281. PubMedDOI

Appears in

Sources

  1. 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):4271-4281.

    PubMedDOI