{"entity":{"id":"cou-aa-302","kind":"trial","name":"COU-AA-302","aka":["COU-AA-302","abiraterone before chemotherapy"],"tldr":"Moved abiraterone in front of chemotherapy, doubling the time before scans showed the cancer growing and putting off the day chemotherapy and opiates were needed.","summary":"COU-AA-302 randomised 1,088 men with metastatic castration-resistant prostate cancer and no previous chemotherapy to abiraterone acetate 1000 mg with prednisone or placebo with prednisone. The study was unblinded after a planned interim analysis at 43 percent of expected deaths.\n\nMedian radiographic progression-free survival was 16.5 months with abiraterone against 8.3 months with prednisone alone, hazard ratio 0.53 (95 percent confidence interval 0.45 to 0.62, p<0.001). Over a median 22.2 months, overall survival was improved, median not reached against 27.2 months, hazard ratio 0.75 (0.61 to 0.93, p=0.01), but did not cross the prespecified efficacy boundary at that analysis.\n\nThe endpoints that describe daily life all favoured abiraterone: time to starting cytotoxic chemotherapy, time to opiate use for cancer-related pain, time to PSA progression and time to decline in performance status. Grade 3 or 4 mineralocorticoid-related adverse events and liver function abnormalities were more common with abiraterone.\n\nIn England NICE TA387 recommends abiraterone with prednisone or prednisolone for metastatic hormone-relapsed prostate cancer in men with no or mild symptoms after androgen deprivation has failed and before chemotherapy is indicated, subject to the commercial access arrangement.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00887198","url":"https://clinicaltrials.gov/study/NCT00887198"},{"label":"COU-AA-302 (New England Journal of Medicine 2013)","url":"https://doi.org/10.1056/NEJMoa1209096"},{"label":"NICE TA387: abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated","url":"https://www.nice.org.uk/guidance/ta387"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation"],"targets":["androgen-receptor"],"drugs":["abiraterone","prednisone"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":["arpi","castration-resistance"],"trials":["cou-aa-301","prevail"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00887198","phase":"3","setting":"Metastatic castration-resistant prostate cancer with no previous chemotherapy: abiraterone acetate 1000 mg with prednisone 5 mg twice daily against placebo with prednisone, with co-primary endpoints of radiographic progression-free survival and overall survival","sponsor":"Janssen Research and Development, formerly Cougar Biotechnology","result":"Median radiographic progression-free survival 16.5 against 8.3 months (hazard ratio 0.53, 95 percent confidence interval 0.45 to 0.62) and overall survival not reached against 27.2 months (0.75, 0.61 to 0.93) before chemotherapy.","yearReported":2013,"enrolled":1088,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic progression-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Abiraterone acetate with prednisone","value":16.5},{"name":"Placebo with prednisone","value":8.3}],"hr":0.53,"ci":[0.45,0.62],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1209096"},{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Abiraterone acetate with prednisone","note":"not reached Did not cross the prespecified efficacy boundary at the interim analysis."},{"name":"Placebo with prednisone","value":27.2}],"hr":0.75,"ci":[0.61,0.93],"p":"0.01","source":"https://doi.org/10.1056/NEJMoa1209096"}],"replication":"PREVAIL found the same for enzalutamide before chemotherapy in 1,717 men, with an overall survival hazard ratio of 0.71."},"route":"/trials/cou-aa-302/","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":"androgen-deprivation","kind":"technology","name":"Androgen deprivation & AR pathway inhibitors","route":"/technologies/androgen-deprivation/"}],"target":[{"id":"androgen-receptor","kind":"target","name":"Androgen receptor","route":"/targets/androgen-receptor/"}],"drug":[{"id":"abiraterone","kind":"drug","name":"Abiraterone acetate","route":"/drugs/abiraterone/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"term":[{"id":"arpi","kind":"term","name":"Androgen receptor pathway inhibitor (ARPI)","route":"/terms/arpi/"},{"id":"castration-resistance","kind":"term","name":"Castration-resistant prostate cancer (CRPC)","route":"/terms/castration-resistance/"},{"id":"prostate-crpc-sequencing","kind":"term","name":"What follows what in castration-resistant prostate cancer","route":"/terms/prostate-crpc-sequencing/"}],"trial":[{"id":"cou-aa-301","kind":"trial","name":"COU-AA-301","route":"/trials/cou-aa-301/"},{"id":"elm-pc-4-orteronel","kind":"trial","name":"ELM-PC 4","route":"/trials/elm-pc-4-orteronel/"},{"id":"prevail","kind":"trial","name":"PREVAIL","route":"/trials/prevail/"}]}}