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Background <p>DAROL is an ongoing study of real-world safety and effectiveness of darolutamide in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC).</p> Subjects/Methods <p>This prespecified interim analysis included 550 patients with nmCRPC who completed ≥6 months of treatment with darolutamide 600 mg twice daily.</p> Results <p>Darolutamide showed consistent safety and effectiveness in DAROL vs ARAMIS. Most treatment-emergent adverse events were grade 1/2. Two-year overall survival and metastasis-free survival rates and prostate-specific antigen responses were similar to ARAMIS.</p> Conclusions <p>These findings indicate that darolutamide offers effectiveness and a favorable safety profile in the broad range of patients seen in clinical practice.</p>

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DARolutamide ObservationaL (DAROL) study in patients with nonmetastatic castration-resistant prostate cancer: prespecified third interim analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月1日

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  • Evan Y. Yu,
  • Hiroyoshi Suzuki,
  • Christopher M. Pieczonka,
  • Geoffrey Gotto,
  • Alberto Briganti,
  • Murilo Luz,
  • Declan Murphy,
  • Ryan Malone,
  • Joelle Hamilton,
  • Jonathan E. Chan,
  • Paul Sieber,
  • Robert W. Given,
  • Eva Hellmis,
  • Thomas Kretz,
  • Philipp Spiegelhalder,
  • Antonio Gómez-Caamaño,
  • Yaovi Messan Amela,
  • Xavier Artignan,
  • Hiroji Uemura,
  • Naoki Fujita,
  • Patrick Adorjan,
  • Mercedeh Ghadessi,
  • Frank Verholen,
  • Andrew J. Armstrong

摘要

Background

DAROL is an ongoing study of real-world safety and effectiveness of darolutamide in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC).

Subjects/Methods

This prespecified interim analysis included 550 patients with nmCRPC who completed ≥6 months of treatment with darolutamide 600 mg twice daily.

Results

Darolutamide showed consistent safety and effectiveness in DAROL vs ARAMIS. Most treatment-emergent adverse events were grade 1/2. Two-year overall survival and metastasis-free survival rates and prostate-specific antigen responses were similar to ARAMIS.

Conclusions

These findings indicate that darolutamide offers effectiveness and a favorable safety profile in the broad range of patients seen in clinical practice.