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Darolutamide For Castration-Resistant Prostate Cancer

Authors Bastos DA, Antonarakis ES

Received 30 July 2019

Accepted for publication 18 September 2019

Published 23 October 2019 Volume 2019:12 Pages 8769—8777

DOI https://doi.org/10.2147/OTT.S197244

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Leo Jen-Liang Su


Diogo A Bastos,1 Emmanuel S Antonarakis2

1Department of Oncology, Hospital Sirio-Libanes, Sao Paulo, SP, Brazil; 2Departments of Oncology and Urology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA

Correspondence: Emmanuel S Antonarakis
Department of Oncology and Urology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, 201 N. Broadway, Skip Viragh Building, Baltimore, MD 21287, USA
Tel +1 443-287-0553
Fax +1 410-614-8397
Email eantona1@jhmi.edu

Abstract: The treatment landscape of advanced prostate cancer continues to evolve rapidly, with newer and more active drugs being used in earlier phases of the disease based on improved overall survival. After adoption of docetaxel for metastatic castration-sensitive disease, large trials with next-generation androgen receptor-signaling inhibitors (abiraterone, enzalutamide and apalutamide) have demonstrate significant improvements in survival and important secondary endpoints. For non-metastatic castration-resistant prostate cancer, recent phase III placebo-controlled trials with enzalutamide, apalutamide and darolutamide all demonstrated benefits in improving metastasis-free survival. This review aims to summarize the clinical development of darolutamide, a novel next-generation androgen receptor antagonist, including preclinical data, clinical studies and the potential of darolutamide for the treatment of advanced prostate cancer. To date, darolutamide efficacy and tolerability has been demonstrated in the ARAMIS trial, which demonstrated an improvement in metastasis-free survival compared to placebo for non-metastatic castration-resistant prostate cancer patients with a rapid PSA doubling time. Ongoing studies will further evaluate the role of darolutamide in metastatic castration-sensitive prostate cancer in combination with docetaxel (ARASENS trial) and also in other stages of the disease.

Keywords: darolutamide, androgen receptor antagonist, prostate cancer, castration-resistant


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