ARASENS
In metastatic hormone-sensitive prostate cancer, does adding darolutamide to ADT plus docetaxel improve overall survival?
Absolute Effect
The addition of darolutamide reduced the risk of death by 32.5% relative to ADT + docetaxel in the primary analysis.
High-volume disease HR 0.69; high-risk disease HR 0.71; low-risk disease HR 0.62; low-volume disease HR 0.68 with wider uncertainty.
Clinical interpretation
The trial was double-blind and international. Most patients had de-novo metastatic disease, so the population should be considered when extrapolating to recurrent metastatic hormone-sensitive disease.
Toxicity / burden
Grade 3–4 adverse events were common in both groups, driven largely by the overlapping docetaxel period: 66.1% with darolutamide versus 63.5% with placebo. Neutropenia was the most common grade 3–4 event.
NNT / NNH
A fixed-time NNT is not calculated from the primary report because the headline result is a hazard ratio without a single corresponding absolute survival estimate at a prespecified time point. A broad grade 3–4 AE NNH would be approximately 38 based on 66.1% vs 63.5%, but this endpoint includes heterogeneous events and should not be interpreted as serious toxicity attributable specifically to darolutamide.