ARASENS
Trial question
What is the effect of darolutamide addition to androgen-deprivation therapy and docetaxel in patients with metastatic, hormone-sensitive prostate cancer?
Study design
Multi-center
Double blinded
RCT
Population
1306 male patients
Inclusion criteria: patients with metastatic, hormone-sensitive prostate cancer
Key exclusion criteria: regional lymph-node involvement only; receipt of androgen-deprivation therapy > 12 weeks before randomization, second-generation androgen-receptor pathway inhibitors, chemotherapy, or immunotherapy for prostate cancer before randomization; radiotherapy within 2 weeks before randomization
Interventions
N=651 darolutamide (combination with androgen-deprivation therapy and docetaxel plus darolutamide 600 mg BID)
N=655 placebo (combination with androgen-deprivation therapy and docetaxel plus matching placebo BID)
Primary outcome
Overall survival
64.8
53.6
64.8 %
48.6 %
32.4 %
16.2 %
0.0 %
Darolutamide
Placebo
Significant increase ▲
NNT = 8
Significant increase in overall survival (64.8% vs. 53.6%; HR 1.5, 95% CI 1.3 to 1.8)
Secondary outcomes
Significant decrease in time to castration-resistant prostate cancer (35% vs. 60%; HR 0.36, 95% CI 0.3 to 0.42)
Significant decrease in time to pain progression (34% vs. 38%; HR 0.79, 95% CI 0.66 to 0.95)
Significant decrease in symptomatic skeletal event-free survival (40% vs. 50%; HR 0.61, 95% CI 0.52 to 0.72)
Safety outcomes
No significant differences in adverse events, grade 3-5 adverse events and serious adverse events.
Conclusion
In patients with metastatic, hormone-sensitive prostate cancer, darolutamide was superior to placebo with respect to overall survival.
Reference
Matthew R Smith, Maha Hussain, Fred Saad et al. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142.
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