{"entity":{"id":"paper-spartan-nejm-2018","kind":"paper","name":"SPARTAN: apalutamide for non-metastatic castration-resistant prostate cancer","aka":[],"tldr":"In men whose PSA was rising rapidly on hormone therapy but who had no visible metastases, apalutamide delayed the appearance of metastases by two years and later showed a survival benefit.","summary":"Phase 3 placebo-controlled trial of 1,207 men with non-metastatic castration-resistant prostate cancer and PSA doubling time of ten months or less randomised 2:1 to apalutamide or placebo with continued androgen deprivation.\n\nMedian metastasis-free survival was 40.5 versus 16.2 months (hazard ratio 0.28), and the final analysis showed median overall survival of 73.9 versus 59.9 months (hazard ratio 0.78); rash, fracture and hypothyroidism were more common with apalutamide.","asOf":"2026-09-17","links":[{"label":"N Engl J Med 2018","url":"https://doi.org/10.1056/NEJMoa1715546"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/29420164/"}],"tags":[],"related":[],"cancers":["prostate-nmcrpc"],"sections":[],"technologies":[],"targets":[],"drugs":["apalutamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2018,"doi":"10.1056/NEJMoa1715546","pmid":"29420164","authors":"Smith MR, Saad F, Chowdhury S, et al.","paperType":"rct","findings":["Median metastasis-free survival 40.5 vs 16.2 months; hazard ratio 0.28.","Median overall survival 73.9 vs 59.9 months; hazard ratio 0.78."],"whatItMeans":"Apalutamide, enzalutamide or darolutamide are standard for high-risk non-metastatic castration-resistant prostate cancer, a setting largely defined by conventional imaging.","caveats":["Most of these men would show metastases on PSMA PET.","Rash in about a quarter of patients."],"changedPractice":true,"participants":1207},"route":"/key-papers/paper-spartan-nejm-2018/","neighbours":{"cancer":[{"id":"prostate-nmcrpc","kind":"cancer","name":"Non-metastatic castration-resistant prostate cancer","route":"/cancers/prostate-nmcrpc/"}],"drug":[{"id":"apalutamide","kind":"drug","name":"Apalutamide","route":"/drugs/apalutamide/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}]}}