Darolutamide added to androgen deprivation therapy (ADT) and docetaxel improves overall survival in men with high-volume and high-risk metastatic hormone-sensitive prostate cancer (mHSPC), according to an analysis of the phase 3 ARASENS trial published in the Journal of Clinical Oncology.

For the trial, investigators randomly assigned men to receive oral darolutamide at 600 mg twice daily or placebo in addition to ADT and docetaxel. Of 1305 men in the trial, 1005 (77%) had high-volume disease and 912 (70%) had high-risk disease.

Among patients with high-volume disease and high-risk disease, the darolutamide arm had a significant 31% and 29% lower risk for death, respectively, compared with the placebo arm. The darolutamide arm had a significant 38% lower risk for death among men with low-risk disease. These findings are consistent with that of the overall study population, the investigators noted.

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In addition, the adverse event (AE) rates were similar between treatment groups across subgroups. Grade 3 or 4 AEs occurred in 64.9% and 64.3% of the darolutamide and placebo arms, respectively, in the high-volume subgroup and 70.2% and 61.2%, respectively, in the low-volume subgroup.

The investigators defined high-volume disease as visceral metastases and/or 4 or more bone metastases with 1 or more beyond the vertebral column/pelvis. They defined high-risk disease as 2 or more risk factors: Gleason score 8 or higher, 3 or more bone lesions, and presence of measurable visceral metastases.

Disclosure: This research was supported by Bayer AG and Orion Pharma. Please see the original reference for a full list of disclosures.


Hussain M, Tombal B, Saad F, et al. Darolutamide plus androgen-deprivation therapy and docetaxel in metastatic hormone-sensitive prostate cancer by disease volume and risk subgroups in the phase III ARASENS trial. J Clin Oncol. Published online February 16, 2023. doi:10.1200/JCO.23.00041

This article originally appeared on Renal and Urology News