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Background <p>This analysis reports efficacy and safety data in the subgroup of Black patients from the ARANOTE phase 3 trial.</p> Methods <p>Patients starting on androgen-deprivation therapy (ADT) were randomised 2:1 to receive darolutamide 600 mg twice daily or placebo. Of the total ARANOTE population (<i>N</i> = 669), 65 patients (10%; darolutamide, <i>n</i> = 41; placebo, <i>n</i> = 24) were Black.</p> Results <p>In Black patients, darolutamide + ADT improved radiological progression-free survival (rPFS), reducing the risk of radiological progression or death by 49% vs ADT alone, consistent with the overall population.</p> Conclusions <p>In Black patients from ARANOTE, darolutamide was associated with improvement in rPFS.</p>

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Efficacy and safety of darolutamide plus androgen-deprivation therapy in Black patients with metastatic hormone-sensitive prostate cancer from the phase 3 ARANOTE trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月20日

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  • Quoc-Dien Trinh,
  • Daniel J. George,
  • Neal Shore,
  • Egils Vjaters,
  • David Olmos,
  • Andrea Juliana P. de Santana Gomes,
  • Augusto Cesar de Andrade Mota,
  • Natasha Littleton,
  • Shankar Srinivasan,
  • Frank Verholen,
  • Kunhi Parambath Haresh,
  • Fred Saad

摘要

Background

This analysis reports efficacy and safety data in the subgroup of Black patients from the ARANOTE phase 3 trial.

Methods

Patients starting on androgen-deprivation therapy (ADT) were randomised 2:1 to receive darolutamide 600 mg twice daily or placebo. Of the total ARANOTE population (N = 669), 65 patients (10%; darolutamide, n = 41; placebo, n = 24) were Black.

Results

In Black patients, darolutamide + ADT improved radiological progression-free survival (rPFS), reducing the risk of radiological progression or death by 49% vs ADT alone, consistent with the overall population.

Conclusions

In Black patients from ARANOTE, darolutamide was associated with improvement in rPFS.