{"entity":{"id":"chaarted","kind":"trial","name":"CHAARTED (E3805)","aka":[],"tldr":"The first trial to show chemotherapy at the start of hormone therapy prolongs life in metastatic prostate cancer.","summary":"CHAARTED, ECOG-ACRIN trial E3805, NCT00309985, reported in 2015, was the first trial to show that giving docetaxel at the start of hormone therapy prolongs life in metastatic hormone-sensitive prostate cancer. It randomised 790 men to androgen deprivation with or without docetaxel and met its primary overall survival endpoint, but in long-term follow-up the benefit was confined to men with high-volume disease. OnCo links it to prostate cancer, docetaxel and Christopher J. Sweeney, and the result was replicated by arm C of the STAMPEDE platform, with the concentration of benefit in high-volume disease shaping how that distinction is used. Whether chemotherapy still earns its place now that triplet regimens and PSMA radioligands have entered this setting is the open question. Docetaxel has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT00309985","url":"https://clinicaltrials.gov/study/NCT00309985"},{"label":"CHAARTED (New England Journal of Medicine 2015)","url":"https://doi.org/10.1056/NEJMoa1503747"}],"tags":[],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel"],"companies":["ecog-acrin"],"institutions":[],"pathways":[],"terms":[],"trials":["getug-afu-15","stampede","rtog-0521"],"people":["christopher-sweeney"],"bottlenecks":[],"keyPapers":["paper-chaarted-nejm-2015"],"journals":[],"dependsOn":[],"notes":["CHAARTED randomised 790 men, median age 63, to androgen deprivation with or without docetaxel 75 mg/m2 every 3 weeks for six cycles. At a median 28.9 months, median overall survival was 13.6 months longer with the combination, 57.6 against 44.0 months. A PSA below 0.2 ng/mL at 12 months was reached by 27.7 against 16.8 percent (p<0.001). In the combination group grade 3 or 4 febrile neutropenia occurred in 6.2 percent, grade 3 or 4 infection with neutropenia in 2.3 percent and grade 3 sensory and motor neuropathy in 0.5 percent each (New England Journal of Medicine 2015).","GETUG-AFU 15, with 385 men, had tested the same question first and found nothing (hazard ratio 1.01). The difference is sample size and metastatic volume, and the pair is the standard example in prostate cancer of a negative trial that was simply too small."],"nct":"NCT00309985","phase":"3","setting":"Metastatic hormone-sensitive prostate cancer: ADT + docetaxel vs ADT","sponsor":"ECOG-ACRIN","result":"OS HR 0.61 overall; high-volume HR 0.63; low-volume no benefit.","started":"2006-09-26","startedType":"actual","yearReported":2015,"enrolled":790,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"ADT + docetaxel","n":397,"value":57.6},{"name":"ADT alone","n":393,"value":44}],"hr":0.61,"ci":[0.47,0.8],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1503747"},{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Androgen deprivation with docetaxel","value":57.6},{"name":"Androgen deprivation alone","value":44}],"hr":0.61,"ci":[0.47,0.8],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1503747"},{"endpoint":"Time to biochemical, symptomatic or radiographic progression (median)","unit":"months","arms":[{"name":"Androgen deprivation with docetaxel","value":20.2},{"name":"Androgen deprivation alone","value":11.7}],"hr":0.61,"ci":[0.51,0.72],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1503747"}],"replication":"Replicated by STAMPEDE arm C; benefit concentrated in high-volume disease."},"route":"/trials/chaarted/","neighbours":{"cancer":[{"id":"prostate-mhspc","kind":"cancer","name":"Metastatic hormone-sensitive prostate cancer","route":"/cancers/prostate-mhspc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"}],"company":[{"id":"ecog-acrin","kind":"company","name":"ECOG-ACRIN Cancer Research Group","route":"/companies/ecog-acrin/"}],"trial":[{"id":"arasens","kind":"trial","name":"ARASENS","route":"/trials/arasens/"},{"id":"getug-afu-15","kind":"trial","name":"GETUG-AFU 15","route":"/trials/getug-afu-15/"},{"id":"rtog-0521","kind":"trial","name":"NRG Oncology RTOG 0521","route":"/trials/rtog-0521/"},{"id":"stampede","kind":"trial","name":"STAMPEDE","route":"/trials/stampede/"},{"id":"swog-9346","kind":"trial","name":"SWOG 9346 (intermittent androgen deprivation)","route":"/trials/swog-9346/"},{"id":"tax-327","kind":"trial","name":"TAX 327","route":"/trials/tax-327/"}],"person":[{"id":"christopher-sweeney","kind":"person","name":"Christopher J. Sweeney","route":"/people/christopher-sweeney/"}],"paper":[{"id":"paper-chaarted-nejm-2015","kind":"paper","name":"CHAARTED: chemohormonal therapy in metastatic hormone-sensitive prostate cancer","route":"/key-papers/paper-chaarted-nejm-2015/"}],"term":[{"id":"prostate-stampede-arms","kind":"term","name":"STAMPEDE's arms, and what each one answered","route":"/terms/prostate-stampede-arms/"}],"roadmap":[{"id":"hormonal-therapy-roadmap","kind":"roadmap","name":"Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test","route":"/roadmaps/hormonal-therapy-roadmap/"}]}}