{"entity":{"id":"nct01946204","kind":"trial","name":"A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer","aka":["SPARTAN"],"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 (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer is a phase 3 interventional study registered as NCT01946204 by Aragon Pharmaceuticals, Inc., with 1207 participants enrolled, started 2013-10-14 and due to reach its primary completion in 2017-05-19. Interventions recorded: Apalutamide and Placebo. Results have been posted on the registry.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT01946204","url":"https://clinicaltrials.gov/study/NCT01946204"},{"label":"SPARTAN (New England Journal of Medicine 2018)","url":"https://doi.org/10.1056/NEJMoa1715546"},{"label":"NICE TA740: apalutamide with androgen deprivation therapy for treating high-risk hormone-relapsed non-metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta740"},{"label":"NICE TA660: darolutamide with androgen deprivation therapy for treating hormone-relapsed non-metastatic prostate cancer","url":"https://www.nice.org.uk/guidance/ta660"},{"label":"NICE TA580: enzalutamide for hormone-relapsed non-metastatic prostate cancer, not recommended","url":"https://www.nice.org.uk/guidance/ta580"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-nmcrpc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["apalutamide"],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":["prostate-uk-drug-approvals"],"trials":["prosper","aramis","nct02489318"],"people":[],"bottlenecks":[],"keyPapers":["paper-spartan-nejm-2018"],"journals":[],"dependsOn":[],"notes":["SPARTAN randomised 1,207 men with non-metastatic castration-resistant prostate cancer and a PSA doubling time of 10 months or less 2:1 to apalutamide 240 mg daily or placebo, all continuing androgen deprivation. The primary analysis was performed after 378 events. Adverse events leading to discontinuation occurred in 10.6 percent on apalutamide and 7.0 percent on placebo; rash occurred in 23.8 against 5.5 percent and hypothyroidism in 8.1 against 2.0 percent (New England Journal of Medicine 2018).","In England NICE TA740 recommends apalutamide with androgen deprivation for hormone-relapsed non-metastatic prostate cancer at high risk of metastasising, defining high risk as a PSA that has doubled in 10 months or less on continuous androgen deprivation. NICE TA660 recommends darolutamide with androgen deprivation for the same population. NICE TA580 does not recommend enzalutamide there: the committee accepted that it extends the time until the cancer spreads, found no evidence that it extends life, and judged the cost-effectiveness estimates too uncertain and outside the usual range.","This disease state is partly an artefact of imaging. Men classified as non-metastatic on CT and bone scan, which is how SPARTAN, PROSPER and ARAMIS staged them, are frequently found to have metastases on PSMA PET."],"nct":"NCT01946204","phase":"3","setting":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer","sponsor":"Aragon Pharmaceuticals, Inc.","result":"Median metastasis-free survival 40.5 months with apalutamide added to androgen deprivation against 16.2 months with placebo (hazard ratio 0.28, 95 percent confidence interval 0.23 to 0.35, p<0.001); rash 23.8 against 5.5 percent and fracture 11.7 against 6.5 percent.","started":"2013-10-14","startedType":"actual","yearReported":2018,"enrolled":1207,"enrolledBasis":"registry","outcomes":[{"endpoint":"Metastasis-free survival (median)","primary":true,"unit":"months","arms":[{"name":"Apalutamide with androgen deprivation","n":806,"value":40.5},{"name":"Placebo with androgen deprivation","n":401,"value":16.2}],"hr":0.28,"ci":[0.23,0.35],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1715546"},{"endpoint":"Time to symptomatic progression","arms":[{"name":"Apalutamide with androgen deprivation","n":806},{"name":"Placebo with androgen deprivation","n":401}],"hr":0.45,"ci":[0.32,0.63],"p":"<0.001","source":"https://doi.org/10.1056/NEJMoa1715546"},{"endpoint":"Fracture, any grade","unit":"%","arms":[{"name":"Apalutamide with androgen deprivation","n":806,"value":11.7},{"name":"Placebo with androgen deprivation","n":401,"value":6.5}],"source":"https://doi.org/10.1056/NEJMoa1715546"}],"replication":"PROSPER with enzalutamide and ARAMIS with darolutamide found metastasis-free survival benefits of the same size in the same setting."},"route":"/trials/nct01946204/","neighbours":{"cancer":[{"id":"prostate-nmcrpc","kind":"cancer","name":"Non-metastatic castration-resistant prostate cancer","route":"/cancers/prostate-nmcrpc/"},{"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/"}],"term":[{"id":"prostate-uk-drug-approvals","kind":"term","name":"Prostate cancer drugs in England: what NICE recommends, and what it refuses","route":"/terms/prostate-uk-drug-approvals/"}],"trial":[{"id":"nct02489318","kind":"trial","name":"A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC","route":"/trials/nct02489318/"},{"id":"aramis","kind":"trial","name":"ARAMIS","route":"/trials/aramis/"},{"id":"prosper","kind":"trial","name":"PROSPER","route":"/trials/prosper/"}],"paper":[{"id":"paper-spartan-nejm-2018","kind":"paper","name":"SPARTAN: apalutamide for non-metastatic castration-resistant prostate cancer","route":"/key-papers/paper-spartan-nejm-2018/"}]}}