Key clinical point: In asymptomatic patients with nonmetastatic castration-resistant prostate cancer (CRPC), darolutamide vs placebo maintains health-related quality of life (QoL).
Major finding: Darolutamide vs placebo significantly delayed time to deterioration of Functional Assessment of Cancer Therapy-Prostate cancer subscale (hazard ratio [HR], 0.80; P = .0005), urinary symptoms (HR, 0.64; P < .0001), and bowel symptoms (HR, 0.78; P = .0027).
Study details: A study of patient-reported health-related QoL from randomized, double-blind, placebo-controlled, phase 3 ARAMIS trial, which evaluated 1,509 patients with nonmetastatic CRPC and prostate-specific antigen doubling time of 10 months or less who were randomly assigned 2:1 to receive darolutamide or placebo while continuing androgen deprivation therapy.
Disclosures: This study was funded by Bayer AG and Orion Pharma. The authors received grants, personal fees, and/or nonfinancial support from various sources. Some authors were employees of pharmaceutical companies.
Source: Smith MR. Eur J Cancer. 2021 Jul 14. doi: 10.1016/j.ejca.2021.06.010 .