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AR Inhibitor Plus Androgen-Deprivation Therapy in Prostate Cancer: ARASENS Update on Disease Volume and Risk

By: Vanessa A. Carter, BS
Posted: Friday, March 17, 2023

Maha H.A. Hussain, MD, FACP, FASCO, of Northwestern University, Feinberg School of Medicine, Chicago, and colleagues conducted the phase III ARASENS study to evaluate the safety and efficacy of androgen-deprivation therapy plus the androgen receptor (AR) inhibitor darolutamide and docetaxel in patients with metastatic prostate cancer. An update from this trial focusing on outcomes by disease volume and risk, presented at the 2023 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (Abstract 15), suggest this treatment combination sets a new standard of care for this patient population.

“In patients with metastatic hormone-sensitive prostate cancer, the benefits of early treatment intensification with darolutamide plus androgen-deprivation therapy plus docetaxel on overall survival and key patient-relevant secondary efficacy endpoints…were similar in patients with high- and low-volume as well as high- and low-risk [disease],” the investigators concluded. “The favorable safety profile of darolutamide was reconfirmed in high/low-volume and high/low-risk populations.”

Of the 1,305 patients with metastatic hormone-sensitive prostate cancer in the study, 77% had high-volume disease, 70% had high-risk disease, 23% had low-volume disease, and 30% had low-risk disease. Participants were randomly assigned to receive 600 mg of darolutamide (n = 651) or placebo (n = 654), plus androgen-deprivation therapy and docetaxel.

Regardless of high- or low-volume disease, treatment that included darolutamide extended overall survival versus the treatment that did not, with hazard ratios of 0.69 and 0.68, respectively. Of note, this overall survival benefit of darolutamide versus placebo was similar among patients with high- and low-risk disease.

Furthermore, clinically relevant secondary endpoints were improved in patients receiving darolutamide versus placebo in both high- and low-volume and -risk subgroups, with hazard ratios in the approximate range of those in the overall population. Of note, the frequency of treatment-emergent adverse events was consistent with the overall patient population across subgroups by disease volume and risk.

Disclosure: For full disclosures of the study authors, visit

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