{"entity":{"id":"prosper","kind":"trial","name":"PROSPER","aka":[],"tldr":"PROSPER showed that enzalutamide delayed the appearance of metastases by about two years, and later helped men live longer, when given at the point where prostate cancer is rising on hormone therapy but has not yet spread on scans.","summary":"PROSPER randomised 1401 men with castration-resistant prostate cancer, no metastases on conventional imaging and a PSA doubling time of ten months or less two to one to enzalutamide or placebo alongside androgen deprivation. The primary endpoint was metastasis-free survival.\n\nEnzalutamide lengthened metastasis-free survival substantially and delayed the time to PSA progression and to further antineoplastic therapy; with longer follow-up overall survival was also improved. Fatigue, hypertension and falls were the main added toxicities. It was approved for this indication in July 2018 and, with SPARTAN (apalutamide) and ARAMIS (darolutamide), defined androgen receptor pathway inhibition as the standard for high-risk non-metastatic castration-resistant disease, a group that PSMA PET imaging has since shrunk.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02003924","url":"https://clinicaltrials.gov/study/NCT02003924"}],"tags":["subtype-trials"],"related":[],"cancers":["prostate-nmcrpc","prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["enzalutamide"],"companies":["pfizer","astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["maha-hussain"],"bottlenecks":[],"keyPapers":["paper-prosper-nejm-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02003924","phase":"3","setting":"Non-metastatic castration-resistant prostate cancer with a PSA doubling time of ten months or less: enzalutamide against placebo, both with continued androgen deprivation","sponsor":"Pfizer (Medivation) and Astellas","result":"Enzalutamide lengthened metastasis-free survival and, with longer follow-up, overall survival compared with placebo; approved in July 2018.","yearReported":2018,"enrolled":1401,"outcomes":[]},"route":"/trials/prosper/","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/"}],"drug":[{"id":"enzalutamide","kind":"drug","name":"Enzalutamide","route":"/drugs/enzalutamide/"}],"company":[{"id":"astellas","kind":"company","name":"Astellas","route":"/companies/astellas/"},{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}],"person":[{"id":"maha-hussain","kind":"person","name":"Maha Hussain","route":"/people/maha-hussain/"}],"paper":[{"id":"paper-prosper-nejm-2018","kind":"paper","name":"PROSPER: enzalutamide in men with non-metastatic castration-resistant prostate cancer","route":"/key-papers/paper-prosper-nejm-2018/"}]}}