{"entity":{"id":"prevail","kind":"trial","name":"PREVAIL","aka":["PREVAIL","MDV3100-04"],"tldr":"Moved enzalutamide in front of chemotherapy, cutting the risk of the cancer showing on scans by four fifths and the risk of death by a third.","summary":"PREVAIL randomised 1,717 men with metastatic castration-resistant prostate cancer who had not had chemotherapy to enzalutamide 160 mg daily or placebo. It was stopped at a planned interim analysis after 540 deaths.\n\nRadiographic progression-free survival at 12 months was 65 percent with enzalutamide against 14 percent with placebo, an 81 percent risk reduction, hazard ratio 0.19 (95 percent confidence interval 0.15 to 0.23, p<0.001). At the data cutoff, 626 of the enzalutamide group (72 percent) and 532 of the placebo group (63 percent) were alive, hazard ratio for death 0.71 (0.60 to 0.84, p<0.001).\n\nSecondary endpoints all favoured enzalutamide: time to starting cytotoxic chemotherapy (hazard ratio 0.35), time to first skeletal-related event (0.72), complete or partial soft-tissue response (59 against 5 percent), time to PSA progression (0.17) and a PSA decline of at least 50 percent (78 against 3 percent), all p<0.001. Fatigue and hypertension were the most common clinically relevant adverse events.\n\nIn England NICE TA377 recommends enzalutamide within its marketing authorisation for metastatic hormone-relapsed prostate cancer in men with no or mild symptoms after androgen deprivation has failed and before chemotherapy is indicated, with the patient access scheme discount.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT01212991","url":"https://clinicaltrials.gov/study/NCT01212991"},{"label":"PREVAIL (New England Journal of Medicine 2014)","url":"https://doi.org/10.1056/NEJMoa1405095"},{"label":"NICE TA377: enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated","url":"https://www.nice.org.uk/guidance/ta377"}],"tags":[],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation"],"targets":["androgen-receptor"],"drugs":["enzalutamide"],"companies":["astellas","pfizer"],"institutions":[],"pathways":[],"terms":["arpi","castration-resistance","psa50"],"trials":["affirm","cou-aa-302"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01212991","phase":"3","setting":"Metastatic castration-resistant prostate cancer progressing despite androgen deprivation and not yet treated with chemotherapy: enzalutamide 160 mg daily against placebo, with co-primary endpoints of radiographic progression-free survival and overall survival","sponsor":"Medivation and Astellas","result":"Radiographic progression-free survival at 12 months 65 against 14 percent (hazard ratio 0.19, 95 percent confidence interval 0.15 to 0.23) and hazard ratio for death 0.71 (0.60 to 0.84) before chemotherapy.","yearReported":2014,"enrolled":1717,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic progression-free survival at 12 months","primary":true,"unit":"%","arms":[{"name":"Enzalutamide 160 mg daily","value":65},{"name":"Placebo","value":14}],"hr":0.19,"ci":[0.15,0.23],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1405095"},{"endpoint":"Overall survival","primary":true,"arms":[{"name":"Enzalutamide 160 mg daily","note":"72 percent alive at data cutoff"},{"name":"Placebo","note":"63 percent alive at data cutoff"}],"hr":0.71,"ci":[0.6,0.84],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1405095"},{"endpoint":"PSA decline of 50 percent or more","unit":"%","arms":[{"name":"Enzalutamide 160 mg daily","value":78},{"name":"Placebo","value":3}],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1405095"}],"replication":"COU-AA-302 found the same for abiraterone before chemotherapy in 1,088 men."},"route":"/trials/prevail/","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":"enzalutamide","kind":"drug","name":"Enzalutamide","route":"/drugs/enzalutamide/"}],"company":[{"id":"astellas","kind":"company","name":"Astellas","route":"/companies/astellas/"},{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}],"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":"psa50","kind":"term","name":"PSA50 / PSA90 response","route":"/terms/psa50/"},{"id":"prostate-crpc-sequencing","kind":"term","name":"What follows what in castration-resistant prostate cancer","route":"/terms/prostate-crpc-sequencing/"}],"trial":[{"id":"affirm","kind":"trial","name":"AFFIRM","route":"/trials/affirm/"},{"id":"armor3-sv","kind":"trial","name":"ARMOR3-SV","route":"/trials/armor3-sv/"},{"id":"cou-aa-302","kind":"trial","name":"COU-AA-302","route":"/trials/cou-aa-302/"}]}}