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Darolutamide Improves MFS in Phase III Nonmetastatic CRPC Trial

Jason M. Broderick @jasoncology
Published: Wednesday, Oct 24, 2018

Scott Fields, MD

Scott Fields, MD
Darolutamide (ODM-201) significantly improved metastasis-free survival (MFS) versus placebo in patients with nonmetastatic castration-resistant prostate cancer (CRPC) enrolled in the phase III ARAMIS trial, according to Bayer and Orion Corporation, the co-developers of the oral androgen receptor antagonist.1

The ongoing phase III ARASENS trial (NCT02799602) is examining darolutamide in combination with standard ADT and docetaxel versus standard ADT and docetaxel alone in patients with metastatic hormone-sensitive prostate cancer.


  1. Phase III Trial of Darolutamide in Patients with Non-metastatic Castration-resistant Prostate Cancer Meets Primary Endpoint. Published October 24, 2018. Accessed October 24, 2018.
  2. Small EJ, Saad F, Chowdhury S et al. SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) versus placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC). J Clin Oncol 36, 2018 (suppl 6s; abstract 161).
  3. Hussain M, Fizazi K, Saad F, et al. PROSPER: A phase 3, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant prostate cancer (M0 CRPC). J Clin Oncol. 2018;36 (suppl 6S; abstr 3).

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