{"entity":{"id":"paper-cou-aa-301-abiraterone-de-bono-nejm-2011","kind":"paper","name":"COU-AA-301: abiraterone and increased survival in metastatic castration-resistant prostate cancer after docetaxel","aka":[],"tldr":"Abiraterone, a pill that blocks androgen synthesis throughout the body, lengthened survival in men with metastatic prostate cancer that had progressed after docetaxel, proving that the disease remains hormone-driven even when castration-resistant.","summary":"Phase 3 placebo-controlled trial of 1,195 men with metastatic castration-resistant prostate cancer previously treated with docetaxel randomised 2:1 to abiraterone plus prednisone or placebo plus prednisone.\n\nMedian overall survival was 14.8 versus 10.9 months (hazard ratio 0.65), with improvements in PSA response, radiographic progression and pain; mineralocorticoid excess (fluid retention, hypokalaemia, hypertension) was the characteristic toxicity.","asOf":"2026-09-17","links":[{"label":"N Engl J Med 2011","url":"https://doi.org/10.1056/NEJMoa1014618"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/21612468/"}],"tags":[],"related":["prostate-roadmap","paper-attard-abiraterone-phase-1-cyp17-jco-2008","paper-scher-affirm-enzalutamide-nejm-2012"],"cancers":["prostate-mcrpc","prostate"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2011,"doi":"10.1056/NEJMoa1014618","pmid":"21612468","authors":"de Bono JS, Logothetis CJ, Molina A, et al.","paperType":"rct","findings":["Median overall survival 14.8 vs 10.9 months; hazard ratio 0.65.","PSA response 29 percent vs 6 percent."],"whatItMeans":"Abiraterone became a standard treatment for metastatic castration-resistant prostate cancer and, after later trials, for hormone-sensitive and high-risk localised disease.","caveats":["Requires concurrent prednisone.","Cross-resistance with enzalutamide limits sequential use."],"changedPractice":true,"participants":1195},"route":"/key-papers/paper-cou-aa-301-abiraterone-de-bono-nejm-2011/","neighbours":{"roadmap":[{"id":"prostate-roadmap","kind":"roadmap","name":"Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch","route":"/roadmaps/prostate-roadmap/"}],"paper":[{"id":"paper-abiraterone-acetate-prostate-n-engl-j-med-2013","kind":"paper","name":"Abiraterone in metastatic prostate cancer without previous chemotherapy","route":"/key-papers/paper-abiraterone-acetate-prostate-n-engl-j-med-2013/"},{"id":"paper-scher-affirm-enzalutamide-nejm-2012","kind":"paper","name":"AFFIRM: increased survival with enzalutamide in prostate cancer after chemotherapy","route":"/key-papers/paper-scher-affirm-enzalutamide-nejm-2012/"},{"id":"paper-attard-abiraterone-phase-1-cyp17-jco-2008","kind":"paper","name":"Phase 1 trial of abiraterone acetate confirms that castration-resistant prostate cancer commonly remains hormone driven","route":"/key-papers/paper-attard-abiraterone-phase-1-cyp17-jco-2008/"}],"cancer":[{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}]}}