ARAMIS: darolutamide in non-metastatic castration-resistant prostate cancer
Darolutamide, an androgen receptor inhibitor that barely enters the brain, delayed metastases by nearly two years in men with non-metastatic castration-resistant prostate cancer with side effects close to placebo, and later showed a survival benefit.
Overview
Phase 3 placebo-controlled trial of 1,509 men with non-metastatic castration-resistant prostate cancer and PSA doubling time of ten months or less randomised 2:1 to darolutamide or placebo with continued androgen deprivation.
Median metastasis-free survival was 40.4 versus 18.4 months (hazard ratio 0.41), three-year overall survival 83 versus 77 percent (hazard ratio 0.69 at final analysis), and adverse events including falls, fractures, seizures and cognitive impairment were similar to placebo.
- Median metastasis-free survival 40.4 vs 18.4 months; hazard ratio 0.41.
- Overall survival hazard ratio 0.69; adverse event rates close to placebo.
Darolutamide is often preferred in older men or those with fall or cognitive concerns because of its favourable tolerability among the three approved agents.
- No head-to-head comparison with enzalutamide or apalutamide.
- Non-metastatic by conventional imaging.
Similar pages
not linked directly; found by shared links- Key paperPROSPER: enzalutamide in men with non-metastatic castration-resistant prostate cancer
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- Key paperSPARTAN: apalutamide for non-metastatic castration-resistant prostate cancer
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- Key paperARASENS: darolutamide added to androgen deprivation and docetaxel in metastatic hormone-sensitive prostate cancer
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