{"entity":{"id":"aranote","kind":"trial","name":"ARANOTE","aka":[],"tldr":"ARANOTE showed that darolutamide added to hormone therapy alone, without chemotherapy, delayed the progression of newly metastatic prostate cancer on scans, extending the drug's use to men who cannot or do not want to have docetaxel.","summary":"ARASENS had established darolutamide with docetaxel and androgen deprivation for metastatic hormone-sensitive prostate cancer. ARANOTE randomised 669 men with metastatic hormone-sensitive disease two to one to androgen deprivation therapy with darolutamide or with placebo, without docetaxel. The primary endpoint was radiographic progression-free survival.\n\nDarolutamide lengthened radiographic progression-free survival with a tolerability profile again close to placebo, and the result led to approval of darolutamide with androgen deprivation alone for metastatic hormone-sensitive disease in 2025. It gave darolutamide the same two-drug indication that apalutamide (TITAN) and enzalutamide (ARCHES, ENZAMET) already held.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT04736199","url":"https://clinicaltrials.gov/study/NCT04736199"}],"tags":["subtype-trials"],"related":[],"cancers":["prostate-mhspc","prostate"],"sections":[],"technologies":[],"targets":[],"drugs":["darolutamide"],"companies":["bayer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["fred-saad"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04736199","phase":"3","setting":"Metastatic hormone-sensitive prostate cancer: androgen deprivation with darolutamide or placebo, without docetaxel","sponsor":"Bayer","result":"Darolutamide plus androgen deprivation lengthened radiographic progression-free survival compared with androgen deprivation alone; approved for this use in 2025.","yearReported":2024,"enrolled":669,"outcomes":[]},"route":"/trials/aranote/","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/"}],"drug":[{"id":"darolutamide","kind":"drug","name":"Darolutamide","route":"/drugs/darolutamide/"}],"company":[{"id":"bayer","kind":"company","name":"Bayer","route":"/companies/bayer/"}],"person":[{"id":"fred-saad","kind":"person","name":"Fred Saad","route":"/people/fred-saad/"}]}}