{"entity":{"id":"tax-327","kind":"trial","name":"TAX 327","aka":["TAX327","TAX 327 study"],"tldr":"The trial that first showed any drug could make men with hormone-resistant prostate cancer live longer. The gain was about two and a half months, and it also reduced pain.","summary":"Before TAX 327 no treatment had been shown to prolong life in hormone-refractory prostate cancer. Mitoxantrone with prednisone was the standard because it relieved pain, not because it worked.\n\nTAX 327 randomised 1,006 men to three-weekly mitoxantrone, three-weekly docetaxel or weekly docetaxel, all with prednisone. Against mitoxantrone, three-weekly docetaxel gave a hazard ratio for death of 0.76 (95 percent confidence interval 0.62 to 0.94, p=0.009 by stratified log-rank) and weekly docetaxel 0.91 (0.75 to 1.11, p=0.36). Median survival was 16.5 months with mitoxantrone, 18.9 months with three-weekly docetaxel and 17.4 months with weekly docetaxel.\n\nThe secondary endpoints tell you what the extra months felt like. A PSA fall of at least 50 percent occurred in 32, 45 and 48 percent respectively (p<0.001 for both docetaxel comparisons). Predefined reductions in pain occurred in 22, 35 (p=0.01) and 31 percent (p=0.08), and improvements in quality of life in 13, 22 (p=0.009) and 23 percent (p=0.005). Adverse events were more common with docetaxel.\n\nThree-weekly docetaxel with prednisone became the standard of care and stayed so for a decade, and it is still the backbone that abiraterone, enzalutamide and cabazitaxel were tested around. In England NICE TA101 recommends docetaxel for hormone-refractory metastatic prostate cancer only if the Karnofsky performance status score is 60 percent or more, with treatment stopped after up to 10 cycles, on severe adverse events or on progression, and repeat courses are not recommended if the disease recurs after a completed course.","status":"positive","asOf":"2026-09-25","links":[{"label":"TAX 327 (New England Journal of Medicine 2004)","url":"https://doi.org/10.1056/NEJMoa040720"},{"label":"NICE TA101: docetaxel for the treatment of hormone-refractory metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta101"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["docetaxel","mitoxantrone","prednisone"],"companies":["sanofi","cctg"],"institutions":[],"pathways":[],"terms":["castration-resistance","psa50","qol-pro","mcrpc-mhspc"],"trials":["swog-9916","tropic","chaarted"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"Metastatic hormone-refractory prostate cancer: prednisone 5 mg twice daily for everyone, with mitoxantrone 12 mg/m2 every three weeks, docetaxel 75 mg/m2 every three weeks, or docetaxel 30 mg/m2 weekly for five of every six weeks, with overall survival as the primary endpoint","sponsor":"Aventis, with the National Cancer Institute of Canada Clinical Trials Group","result":"Median survival 18.9 months with three-weekly docetaxel against 16.5 months with mitoxantrone (hazard ratio for death 0.76, 95 percent confidence interval 0.62 to 0.94, p=0.009), with more pain relief (35 against 22 percent) and quality-of-life improvement (22 against 13 percent).","yearReported":2004,"enrolled":1006,"enrolledBasis":"randomised","enrolledNote":"1,006 men were randomised between March 2000 and June 2002; the trial predates the 2005 requirement to register, and no ClinicalTrials.gov record can be matched to it with confidence, so none is quoted.","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Docetaxel 75 mg/m2 every 3 weeks with prednisone","value":18.9,"note":"Hazard ratio is three-weekly docetaxel against mitoxantrone; weekly docetaxel gave 0.91 (0.75 to 1.11, p=0.36)."},{"name":"Docetaxel 30 mg/m2 weekly with prednisone","value":17.4},{"name":"Mitoxantrone 12 mg/m2 every 3 weeks with prednisone","value":16.5}],"hr":0.76,"ci":[0.62,0.94],"p":"0.009","source":"https://doi.org/10.1056/NEJMoa040720"},{"endpoint":"Pain response","unit":"%","arms":[{"name":"Docetaxel every 3 weeks","value":35},{"name":"Docetaxel weekly","value":31},{"name":"Mitoxantrone","value":22}],"p":"0.01","source":"https://doi.org/10.1056/NEJMoa040720"},{"endpoint":"Quality of life improvement","unit":"%","arms":[{"name":"Docetaxel every 3 weeks","value":22},{"name":"Docetaxel weekly","value":23},{"name":"Mitoxantrone","value":13}],"p":"0.009","source":"https://doi.org/10.1056/NEJMoa040720"}],"replication":"SWOG 9916, published in the same issue, found docetaxel with estramustine also better than mitoxantrone with prednisone (median survival 17.5 against 15.6 months)."},"route":"/trials/tax-327/","neighbours":{"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/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"mitoxantrone","kind":"drug","name":"Mitoxantrone","route":"/drugs/mitoxantrone/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"}],"company":[{"id":"cctg","kind":"company","name":"Canadian Cancer Trials Group (CCTG)","route":"/companies/cctg/"},{"id":"sanofi","kind":"company","name":"Sanofi","route":"/companies/sanofi/"}],"term":[{"id":"castration-resistance","kind":"term","name":"Castration-resistant prostate cancer (CRPC)","route":"/terms/castration-resistance/"},{"id":"mcrpc-mhspc","kind":"term","name":"mCRPC and mHSPC (castration-resistant vs hormone-sensitive prostate cancer)","route":"/terms/mcrpc-mhspc/"},{"id":"psa50","kind":"term","name":"PSA50 / PSA90 response","route":"/terms/psa50/"},{"id":"qol-pro","kind":"term","name":"Quality of life and patient-reported outcomes (QoL, PRO)","route":"/terms/qol-pro/"},{"id":"prostate-crpc-sequencing","kind":"term","name":"What follows what in castration-resistant prostate cancer","route":"/terms/prostate-crpc-sequencing/"}],"trial":[{"id":"calgb-90401","kind":"trial","name":"CALGB 90401","route":"/trials/calgb-90401/"},{"id":"chaarted","kind":"trial","name":"CHAARTED (E3805)","route":"/trials/chaarted/"},{"id":"cou-aa-301","kind":"trial","name":"COU-AA-301","route":"/trials/cou-aa-301/"},{"id":"firstana","kind":"trial","name":"FIRSTANA","route":"/trials/firstana/"},{"id":"swog-9916","kind":"trial","name":"SWOG 9916","route":"/trials/swog-9916/"},{"id":"swog-s0421-atrasentan","kind":"trial","name":"SWOG S0421","route":"/trials/swog-s0421-atrasentan/"},{"id":"synergy-custirsen","kind":"trial","name":"SYNERGY","route":"/trials/synergy-custirsen/"},{"id":"tropic","kind":"trial","name":"TROPIC","route":"/trials/tropic/"}]}}