{"entity":{"id":"nct02257736","kind":"trial","name":"An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)","aka":[],"tldr":"A phase 3 trial of Apalutamide, Abiraterone acetate and Prednisone in prostate cancer, run by Aragon Pharmaceuticals, Inc., active and no longer recruiting.","summary":"An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) is a phase 3 interventional study registered as NCT02257736 by Aragon Pharmaceuticals, Inc., with 982 participants enrolled, started 2014-11-26 and due to reach its primary completion in 2018-03-19. Interventions recorded: Apalutamide, Abiraterone acetate, Prednisone and Placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02257736","url":"https://clinicaltrials.gov/study/NCT02257736"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["apalutamide","abiraterone","prednisone"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct02257736-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02257736","phase":"3","setting":"A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)","sponsor":"Aragon Pharmaceuticals, Inc.","started":"2014-11-26","startedType":"actual","yearReported":2021,"enrolled":982,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic Progression-free Survival (rPFS)","primary":true,"unit":"months","arms":[{"name":"Placebo+ Abiraterone Acetate - Prednisolone","n":490,"value":16.59,"note":"95% CI 13.86 to 19.32; Figures from the ClinicalTrials.gov results section (first posted 2021-08-16), not from a publication"},{"name":"Apalutamide + Abiraterone Acetate - Prednisolone","n":492,"value":23.98,"note":"95% CI 19.71 to 27.50"}],"source":"https://clinicaltrials.gov/study/NCT02257736?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Placebo+ Abiraterone Acetate - Prednisolone","n":490,"value":33.71,"note":"95% CI 31.24 to 38.28; Figures from the ClinicalTrials.gov results section (first posted 2021-08-16), not from a publication"},{"name":"Apalutamide + Abiraterone Acetate - Prednisolone","n":492,"value":36.17,"note":"95% CI 32.76 to 38.77"}],"source":"https://clinicaltrials.gov/study/NCT02257736?tab=results"}]},"route":"/trials/nct02257736/","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/"}],"drug":[{"id":"abiraterone","kind":"drug","name":"Abiraterone acetate","route":"/drugs/abiraterone/"},{"id":"apalutamide","kind":"drug","name":"Apalutamide","route":"/drugs/apalutamide/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"paper":[{"id":"paper-nct02257736-lancet-oncol-2021","kind":"paper","name":"Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 study","route":"/key-papers/paper-nct02257736-lancet-oncol-2021/"}]}}