Darolutamide improves survival in patients with nonmetastatic castration-resistant prostate cancer
According to a new study, darolutamide provided significant improvement in survival and was favorably tolerated in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) who have stopped responding to standard hormonal therapy. This study was published in the journal, European Urology.
1509 patients were enrolled, 469 had prostate-specific antigen doubling time (PSADT) >6 months (darolutamide n = 286; placebo n = 183) and 1040 had PSADT ≤6 months (darolutamide n = 669; placebo n = 371). Patients were randomized to either receive oral darolutamide 600 mg twice in a day or placebo, while continuing androgen-deprivation therapy. Primary endpoint of this study was metastasis-free survival (MFS) and safety was recorded throughout the study.
Darolutamide significantly prolonged MFS compared to placebo in both subgroups PSADT >6 months and PSADT ≤6 months. Overall survival (OS), other efficacy and quality of life (QoL) endpoints showed significant improvement in the darolutamide subgroups versus the placebo subgroups.
This study demonstrated that darolutamide provided a favorable benefit/risk ratio characterized by significant improvements in MFS, OS, and other clinically relevant endpoints. It also maintained QoL and was favorably tolerated in patients with nmCRPC and PSADT >6 months.
Darolutamide improves survival in patients with nonmetastatic castration-resistant prostate cancer
According to a new study, darolutamide provided significant improvement in survival and was favorably tolerated in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) who have stopped responding to standard hormonal therapy. This study was published in the journal, European Urology.
1509 patients were enrolled, 469 had prostate-specific antigen doubling time (PSADT) >6 months (darolutamide n = 286; placebo n = 183) and 1040 had PSADT ≤6 months (darolutamide n = 669; placebo n = 371). Patients were randomized to either receive oral darolutamide 600 mg twice in a day or placebo, while continuing androgen-deprivation therapy. Primary endpoint of this study was metastasis-free survival (MFS) and safety was recorded throughout the study.
Darolutamide significantly prolonged MFS compared to placebo in both subgroups PSADT >6 months and PSADT ≤6 months. Overall survival (OS), other efficacy and quality of life (QoL) endpoints showed significant improvement in the darolutamide subgroups versus the placebo subgroups.
This study demonstrated that darolutamide provided a favorable benefit/risk ratio characterized by significant improvements in MFS, OS, and other clinically relevant endpoints. It also maintained QoL and was favorably tolerated in patients with nmCRPC and PSADT >6 months.