{"entity":{"id":"eortc-22961","kind":"trial","name":"EORTC 22961","aka":["EORTC 22961","duration of androgen suppression trial"],"tldr":"Tried to show that six months of hormone therapy with radiotherapy is enough for locally advanced prostate cancer. It is not: three years works better.","summary":"EORTC 22961 registered 1,113 men with locally advanced prostate cancer who had already received external beam radiotherapy and 6 months of androgen suppression, and randomised 970 of them to stop (483) or to continue a luteinising hormone-releasing hormone agonist for a further 2.5 years (487). Short-term suppression would have been declared non-inferior if the hazard ratio for overall survival stayed below 1.35.\n\nAt a median 6.4 years, 132 men in the short arm and 98 in the long arm had died, 47 and 29 of them from prostate cancer. Five-year overall mortality was 19.0 percent with short suppression and 15.2 percent with long, and the observed hazard ratio was 1.42 (upper 95.71 percent confidence limit 1.79). Non-inferiority failed (p=0.65). An interim analysis had already shown futility.\n\nThe trial is the reason three years, not six months, is the standard duration of androgen deprivation alongside radiotherapy for locally advanced disease, and the reason a man in that position is asked to accept three years of hot flushes, fatigue, loss of libido and bone loss. Adverse events in both arms included fatigue, diminished sexual function and hot flushes.","status":"negative","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00003026","url":"https://clinicaltrials.gov/study/NCT00003026"},{"label":"EORTC 22961 (New England Journal of Medicine 2009)","url":"https://doi.org/10.1056/NEJMoa0810095"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk"],"sections":[],"technologies":["androgen-deprivation","imrt-igrt"],"targets":[],"drugs":[],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":["adt","hormone-therapy","curative-intent","qol-pro"],"trials":["rtog-9202","dart-01-05-gicor","eortc-22863"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00003026","phase":"3","setting":"Locally advanced prostate cancer after external beam radiotherapy and 6 months of androgen suppression: stop there, or continue a luteinising hormone-releasing hormone agonist for a further 2.5 years, with a non-inferiority design for overall survival","sponsor":"European Organisation for Research and Treatment of Cancer","result":"Five-year overall mortality 19.0 percent with 6 months of androgen suppression against 15.2 percent with 3 years; hazard ratio 1.42, non-inferiority not shown (p=0.65).","yearReported":2009,"enrolled":970,"enrolledBasis":"randomised","enrolledNote":"1,113 men were registered and 970 were randomised after 6 months of androgen suppression; the randomised figure is the one analysed.","outcomes":[{"endpoint":"Overall mortality at 5 years","primary":true,"unit":"%","arms":[{"name":"Short suppression, 6 months","n":483,"value":19,"note":"Upper 95.71 percent confidence limit 1.79."},{"name":"Long suppression, 3 years","n":487,"value":15.2}],"hr":1.42,"p":"0.65 for non-inferiority","source":"https://doi.org/10.1056/NEJMoa0810095"}],"replication":"RTOG 9202 (1,554 men) found the same direction for 28 months against 4 months, and DART 01/05 GICOR (355 men) for 28 months against 4 months with high-dose radiotherapy."},"route":"/trials/eortc-22961/","neighbours":{"cancer":[{"id":"prostate-high-risk","kind":"cancer","name":"Localised prostate cancer, high and very high risk","route":"/cancers/prostate-high-risk/"},{"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/"},{"id":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"}],"company":[{"id":"curie-nki-eortc","kind":"company","name":"EORTC","route":"/companies/curie-nki-eortc/"}],"term":[{"id":"adt","kind":"term","name":"Androgen deprivation therapy (ADT)","route":"/terms/adt/"},{"id":"curative-intent","kind":"term","name":"Curative intent vs palliative intent","route":"/terms/curative-intent/"},{"id":"hormone-therapy","kind":"term","name":"Hormone therapy","route":"/terms/hormone-therapy/"},{"id":"qol-pro","kind":"term","name":"Quality of life and patient-reported outcomes (QoL, PRO)","route":"/terms/qol-pro/"},{"id":"prostate-adt-burden","kind":"term","name":"What androgen deprivation costs: the side of hormone therapy the survival curves do not show","route":"/terms/prostate-adt-burden/"}],"trial":[{"id":"dart-01-05-gicor","kind":"trial","name":"DART 01/05 GICOR","route":"/trials/dart-01-05-gicor/"},{"id":"eortc-22863","kind":"trial","name":"EORTC 22863","route":"/trials/eortc-22863/"},{"id":"rtog-9202","kind":"trial","name":"RTOG 92-02","route":"/trials/rtog-9202/"}]}}