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ARASENS

Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer

Phase 3N = 1,306NCT02799602

Population
Men with metastatic hormone-sensitive prostate cancer (86.1% metastatic at initial diagnosis)
Design
International randomized (1:1) phase 3 trial: darolutamide 600 mg twice daily or matching placebo, both with ADT and docetaxel. Primary end point overall survival.
Primary endpoint
OS
Arms
  • Placebo plus ADT and docetaxel (control, n = 655): Matching placebo plus ADT plus docetaxel
  • Darolutamide plus ADT and docetaxel (experimental, n = 651): Darolutamide 600 mg twice daily plus ADT plus docetaxel
People
Smith MR, ARASENS Trial Investigators
OSHR 0.68 (95% CI 0.57–0.80)
Show the numbers
Results reported for ARASENS
EndpointAnalysisDarolutamide plus ADT and docetaxelPlacebo plus ADT and docetaxelEffect
OSPatients in the primary analysis (population label not stated in the abstract)primarySmith 2022——HR 0.68 (95% CI 0.57–0.80)P<0.001The abstract describes this as a 32.5% lower risk of death; it gives no medians. Grade 3 or 4 adverse events: 66.1% with darolutamide and 63.5% with placebo.
Results reported for ARASENS
EndpointAnalysisDarolutamide plus ADT and docetaxelPlacebo plus ADT and docetaxelEffect
OSPatients in the primary analysis (population label not stated in the abstract)primarySmith 2022——HR 0.68 (95% CI 0.57–0.80)P<0.001The abstract describes this as a 32.5% lower risk of death; it gives no medians. Grade 3 or 4 adverse events: 66.1% with darolutamide and 63.5% with placebo.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.680.57–0.8
Primary publication: Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, et al. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022;386(12):1132-1142. PubMedDOI

Appears in

Sources

  1. Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, et al. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022;386(12):1132-1142.

    PubMedDOI