{"entity":{"id":"nct02489318","kind":"trial","name":"A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC","aka":["TITAN"],"tldr":"A phase 3 trial of Apalutamide in prostate cancer, run by Aragon Pharmaceuticals, Inc., active and no longer recruiting.","summary":"A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC is a phase 3 interventional study registered as NCT02489318 by Aragon Pharmaceuticals, Inc., with 1052 participants enrolled, started 2015-11-27 and due to reach its primary completion in 2020-09-07. Interventions recorded: Apalutamide, Placebo, Androgen Deprivation Therapy (ADT). Conditions listed: Prostate Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02489318","url":"https://clinicaltrials.gov/study/NCT02489318"},{"label":"TITAN (New England Journal of Medicine 2019)","url":"https://doi.org/10.1056/NEJMoa1903307"},{"label":"NICE TA741: apalutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta741"},{"label":"NICE TA1109: darolutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta1109"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["apalutamide"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":["arches","enzamet","latitude","aranote","nct01946204"],"people":[],"bottlenecks":[],"keyPapers":["paper-nct02489318-n-engl-j-med-2019"],"journals":[],"dependsOn":[],"notes":["TITAN was a double-blind phase 3 trial in men with metastatic castration-sensitive prostate cancer, randomised to apalutamide 240 mg daily or placebo added to androgen deprivation. Previous treatment for localised disease and previous docetaxel were allowed. Median age was 68; 16.4 percent had had prostatectomy or radiotherapy for localised disease and 10.7 percent previous docetaxel; 62.7 percent had high-volume and 37.3 percent low-volume disease. At the first interim analysis, median follow-up 22.7 months, both primary endpoints were met. Grade 3 or 4 adverse events occurred in 42.2 percent on apalutamide and 40.8 percent on placebo, with rash more common on apalutamide (New England Journal of Medicine 2019).","In England NICE TA741 recommends apalutamide with androgen deprivation for hormone-sensitive metastatic prostate cancer only if docetaxel is not suitable. NICE TA1109 makes the same restriction for darolutamide with androgen deprivation and instructs prescribers to use the least expensive of the suitable options, which includes apalutamide, taking account of administration costs, dosages, price per dose and commercial arrangements."],"nct":"NCT02489318","phase":"3","setting":"A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","sponsor":"Aragon Pharmaceuticals, Inc.","result":"Radiographic progression-free survival at 24 months 68.2 percent with apalutamide added to androgen deprivation against 47.5 percent with placebo (hazard ratio 0.48, 95 percent confidence interval 0.39 to 0.60) and overall survival at 24 months 82.4 against 73.5 percent (0.67, 0.51 to 0.89).","started":"2015-11-27","startedType":"actual","yearReported":2019,"enrolled":1052,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic progression-free survival at 24 months","primary":true,"unit":"%","arms":[{"name":"Apalutamide with androgen deprivation","n":525,"value":68.2},{"name":"Placebo with androgen deprivation","n":527,"value":47.5}],"hr":0.48,"ci":[0.39,0.6],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1903307"},{"endpoint":"Overall survival at 24 months","primary":true,"unit":"%","arms":[{"name":"Apalutamide with androgen deprivation","n":525,"value":82.4},{"name":"Placebo with androgen deprivation","n":527,"value":73.5}],"hr":0.67,"ci":[0.51,0.89],"p":"0.005","source":"https://doi.org/10.1056/NEJMoa1903307"}],"replication":"ARCHES and ENZAMET found the same for enzalutamide, LATITUDE and the STAMPEDE abiraterone comparison for abiraterone, and ARANOTE for darolutamide."},"route":"/trials/nct02489318/","neighbours":{"cancer":[{"id":"prostate-mhspc","kind":"cancer","name":"Metastatic hormone-sensitive prostate cancer","route":"/cancers/prostate-mhspc/"},{"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/"}],"trial":[{"id":"nct01946204","kind":"trial","name":"A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer","route":"/trials/nct01946204/"},{"id":"aranote","kind":"trial","name":"ARANOTE","route":"/trials/aranote/"},{"id":"arches","kind":"trial","name":"ARCHES","route":"/trials/arches/"},{"id":"enzamet","kind":"trial","name":"ENZAMET","route":"/trials/enzamet/"},{"id":"latitude","kind":"trial","name":"LATITUDE","route":"/trials/latitude/"}],"paper":[{"id":"paper-nct02489318-n-engl-j-med-2019","kind":"paper","name":"Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer","route":"/key-papers/paper-nct02489318-n-engl-j-med-2019/"}]}}