{"entity":{"id":"nct03767244","kind":"trial","name":"A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy","aka":["PROTEUS"],"tldr":"A phase 3 trial of Apalutamide in prostate cancer, run by Janssen Research & Development, LLC, active and no longer recruiting.","summary":"A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy is a phase 3 interventional study registered as NCT03767244 by Janssen Research & Development, LLC, with 2517 participants enrolled, started 2019-06-11 and due to reach its primary completion in 2026-12-01. Interventions recorded: Apalutamide, Androgen Deprivation Therapy (ADT) and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03767244","url":"https://clinicaltrials.gov/study/NCT03767244"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["apalutamide"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03767244-n-engl-j-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03767244","phase":"3","setting":"A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy","sponsor":"Janssen Research & Development, LLC","participation":[{"nct":"NCT03767244","source":"https://clinicaltrials.gov/study/NCT03767244","fetchedAt":"2026-10-07T16:53:07.935Z","studySha256":"022ebae4148a8bc1cf5cb1d5c44e2f7336edda542caadb0591ca304aa1d2cadf","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-09-25","leadSponsor":"Janssen Research & Development, LLC","collaboratorCount":0,"minimumAge":"18 Years","sex":"MALE","healthyVolunteers":false,"hasEligibility":true,"enrolment":2517,"enrolmentType":"ACTUAL","siteCount":203,"recruitingSiteCount":0,"countries":["Argentina","Australia","Brazil","Canada","Czechia","France","Germany","Israel","Italy","Japan","Netherlands","Poland","Russia","South Korea","Spain","Taiwan","United Kingdom","United States"]}],"started":"2019-06-11","startedType":"actual","enrolled":2517,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct03767244/","neighbours":{"cancer":[{"id":"prostate-high-risk","kind":"cancer","name":"Localised prostate cancer, high and very high risk","route":"/cancers/prostate-high-risk/"},{"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":"apalutamide","kind":"drug","name":"Apalutamide","route":"/drugs/apalutamide/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"paper":[{"id":"paper-nct03767244-n-engl-j-med-2026","kind":"paper","name":"Perioperative Apalutamide in High-Risk Localized Prostate Cancer","route":"/key-papers/paper-nct03767244-n-engl-j-med-2026/"}]}}