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Darolutamide, a potent androgen receptor inhibitor, is associated with increased overall survival in patients with non-metastatic castration-resistant prostate cancer
.
Whether the combination of dalolutamide, androgen deprivation therapy, and docetaxel increases survival in patients with metastatic, hormone-sensitive prostate cancer is unknown
In this international phase 3 trial, researchers randomly assigned patients with metastatic hormone-sensitive prostate cancer in a 1:1 ratio to receive dalolutamide (at a dose of 600 mg).
[two 300 mg tablets] twice daily) or matching placebo treatment, both in combination with androgen deprivation therapy and docetaxel
.
The primary endpoint of the study was overall survival
The primary analysis of the study involved 1306 patients (651 in the dalolutamide group and 655 in the placebo group); 86.
1% of patients had metastatic disease at the time of initial diagnosis
.
At the data cutoff date of the primary analysis (October 25, 2021), the risk of death was significantly lower in the dalolutamide group than in the placebo group by 32.
diagnosis
Dalorutamide was also associated with sustained benefit in secondary endpoints and in prespecified subgroups
.
Adverse events were similar in the two groups, with the most common adverse event (occurring in ≥10% of patients) occurring at the highest rate during overlapping docetaxel treatment in the two groups
CONCLUSIONS : In this trial involving patients with metastatic hormone-sensitive prostate cancer, overall survival was significantly longer with the combination of dalolutamide, androgen deprivation therapy, and docetaxel than with placebo plus androgen deprivation therapy and more Setaxel, and the addition of dalolutamide resulted in an improvement in key secondary endpoints
.
The incidence of adverse events was similar in the two groups
Overall survival was significantly longer with the combination of dalolutamide, androgen deprivation therapy, and docetaxel than with placebo plus androgen deprivation therapy and docetaxel, and the addition of dalolutamide resulted in an improvement in key secondary endpoints
