{"entity":{"id":"paper-aramis-nejm-2019","kind":"paper","name":"ARAMIS: darolutamide in non-metastatic castration-resistant prostate cancer","aka":[],"tldr":"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.","summary":"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.\n\nMedian 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.","asOf":"2026-09-17","links":[{"label":"N Engl J Med 2019","url":"https://doi.org/10.1056/NEJMoa1815671"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/30763142/"}],"tags":[],"related":[],"cancers":["prostate-nmcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["darolutamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["aramis"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2019,"doi":"10.1056/NEJMoa1815671","pmid":"30763142","authors":"Fizazi K, Shore N, Tammela TL, et al.","paperType":"rct","findings":["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."],"whatItMeans":"Darolutamide is often preferred in older men or those with fall or cognitive concerns because of its favourable tolerability among the three approved agents.","caveats":["No head-to-head comparison with enzalutamide or apalutamide.","Non-metastatic by conventional imaging."],"changedPractice":true,"participants":1509},"route":"/key-papers/paper-aramis-nejm-2019/","neighbours":{"cancer":[{"id":"prostate-nmcrpc","kind":"cancer","name":"Non-metastatic castration-resistant prostate cancer","route":"/cancers/prostate-nmcrpc/"}],"drug":[{"id":"darolutamide","kind":"drug","name":"Darolutamide","route":"/drugs/darolutamide/"}],"trial":[{"id":"aramis","kind":"trial","name":"ARAMIS","route":"/trials/aramis/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}]}}