{"entity":{"id":"paper-arasens-nejm-2022","kind":"paper","name":"ARASENS: darolutamide added to androgen deprivation and docetaxel in metastatic hormone-sensitive prostate cancer","aka":[],"tldr":"Adding the androgen receptor inhibitor darolutamide to hormone therapy and docetaxel chemotherapy cut deaths by a third in metastatic hormone-sensitive prostate cancer, establishing triplet therapy for men fit for chemotherapy.","summary":"Phase 3 placebo-controlled trial of 1,306 men with metastatic hormone-sensitive prostate cancer randomised to androgen deprivation plus docetaxel with darolutamide or placebo.\n\nFour-year overall survival was 62.7 versus 50.4 percent (hazard ratio 0.68), with delayed castration resistance, pain progression and skeletal events, and no meaningful increase in toxicity beyond docetaxel; benefit was seen in both high- and low-volume disease.","asOf":"2026-09-17","links":[{"label":"N Engl J Med 2022","url":"https://doi.org/10.1056/NEJMoa2119115"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/35179323/"}],"tags":[],"related":[],"cancers":["prostate-mhspc"],"sections":[],"technologies":[],"targets":[],"drugs":["darolutamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["arasens"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2022,"doi":"10.1056/NEJMoa2119115","pmid":"35179323","authors":"Smith MR, Hussain M, Saad F, et al.","paperType":"rct","findings":["Four-year overall survival 62.7 percent vs 50.4 percent; hazard ratio 0.68.","Time to castration-resistant disease hazard ratio 0.36."],"whatItMeans":"Triplet therapy with darolutamide is a standard for fit men with metastatic hormone-sensitive prostate cancer, particularly high-volume disease; PEACE-1 showed the same with abiraterone.","caveats":["No arm of androgen deprivation plus darolutamide without docetaxel, so the contribution of docetaxel is unproven.","Most patients had high-volume disease."],"changedPractice":true,"participants":1306},"route":"/key-papers/paper-arasens-nejm-2022/","neighbours":{"cancer":[{"id":"prostate-mhspc","kind":"cancer","name":"Metastatic hormone-sensitive prostate cancer","route":"/cancers/prostate-mhspc/"}],"drug":[{"id":"darolutamide","kind":"drug","name":"Darolutamide","route":"/drugs/darolutamide/"}],"trial":[{"id":"arasens","kind":"trial","name":"ARASENS","route":"/trials/arasens/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}]}}