{"entity":{"id":"eortc-22911","kind":"trial","name":"EORTC 22911","aka":["EORTC 22911"],"tldr":"Radiotherapy given straight after prostate surgery kept the PSA down for longer, but over ten years that did not translate into fewer men whose disease actually progressed, and side effects were commoner.","summary":"EORTC 22911 randomised 1,005 men with prostate cancer extending beyond the prostate after radical prostatectomy to 60 Gy of conventional postoperative irradiation over 6 weeks or to a wait-and-see policy until biochemical progression, defined as a PSA above 0.2 micrograms per litre confirmed twice at least 2 weeks apart. Median follow-up was 10.6 years, range 2 months to 16.6 years.\n\nPostoperative irradiation significantly improved biochemical progression-free survival: 198 of 502 men (39.4 percent) against 311 of 503 (61.8 percent) had biochemical or clinical progression or died, hazard ratio 0.49 (95 percent confidence interval 0.41 to 0.59, p<0.0001).\n\nThe qualifications are as important as the result. Improvements in clinical progression-free survival were not maintained at 10 years. Late adverse effects of any type and any grade were more frequent after irradiation: 10-year cumulative incidence 70.8 percent (66.6 to 75.0) against 59.7 percent (55.3 to 64.1), p=0.001. Exploratory analyses suggested benefit in men under 70 and in those with positive surgical margins, and possible harm in men aged 70 or older.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00002511","url":"https://clinicaltrials.gov/study/NCT00002511"},{"label":"EORTC 22911 long-term results (Lancet 2012)","url":"https://doi.org/10.1016/S0140-6736(12)61253-7"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk","prostate-bcr"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["curie-nki-eortc"],"institutions":[],"pathways":[],"terms":["prostatectomy","neoadjuvant-adjuvant","biochemical-recurrence"],"trials":["swog-8794","radicals-rt","artistic-meta-analysis"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00002511","phase":"3","setting":"cT0 to T3 prostate cancer extending beyond the prostate after radical prostatectomy, in men 75 or younger: 60 Gy postoperative irradiation to the surgical bed over 6 weeks against a wait-and-see policy until biochemical progression, with biochemical progression-free survival as the primary endpoint","sponsor":"European Organisation for Research and Treatment of Cancer","result":"Biochemical progression-free survival hazard ratio 0.49 (95 percent confidence interval 0.41 to 0.59) at a median 10.6 years, but no maintained clinical progression-free survival benefit and a 10-year late adverse effect incidence of 70.8 against 59.7 percent.","yearReported":2012,"enrolled":1005,"enrolledBasis":"randomised","enrolledNote":"1,005 men from 37 European institutions were randomised, 502 to postoperative irradiation and 503 to a wait-and-see policy.","outcomes":[{"endpoint":"Biochemical or clinical progression or death","primary":true,"unit":"%","arms":[{"name":"Postoperative irradiation, 60 Gy","n":502,"value":39.4},{"name":"Wait and see","n":503,"value":61.8}],"hr":0.49,"ci":[0.41,0.59],"p":"<0.0001","source":"https://doi.org/10.1016/S0140-6736(12)61253-7"},{"endpoint":"Late adverse effects of any grade at 10 years","unit":"%","arms":[{"name":"Postoperative irradiation, 60 Gy","n":502,"value":70.8},{"name":"Wait and see","n":503,"value":59.7}],"p":"0.001","source":"https://doi.org/10.1016/S0140-6736(12)61253-7"}],"replication":"SWOG 8794 found a metastasis-free and overall survival benefit in pT3N0M0 disease; the ARTISTIC meta-analysis later found no event-free survival advantage for adjuvant over early salvage radiotherapy."},"route":"/trials/eortc-22911/","neighbours":{"cancer":[{"id":"prostate-bcr","kind":"cancer","name":"Biochemical recurrence of prostate cancer","route":"/cancers/prostate-bcr/"},{"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":"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":"biochemical-recurrence","kind":"term","name":"Biochemical recurrence (BCR)","route":"/terms/biochemical-recurrence/"},{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"},{"id":"prostatectomy","kind":"term","name":"Radical prostatectomy","route":"/terms/prostatectomy/"}],"trial":[{"id":"artistic-meta-analysis","kind":"trial","name":"ARTISTIC meta-analysis","route":"/trials/artistic-meta-analysis/"},{"id":"radicals-rt","kind":"trial","name":"RADICALS-RT","route":"/trials/radicals-rt/"},{"id":"swog-8794","kind":"trial","name":"SWOG 8794","route":"/trials/swog-8794/"}]}}