{"entity":{"id":"rtog-9408","kind":"trial","name":"RTOG 94-08","aka":["RTOG 9408","RTOG 94-08"],"tldr":"Four months of hormone therapy added to radiotherapy helped men with intermediate-risk prostate cancer live longer, and did nothing for men with low-risk disease.","summary":"RTOG 94-08 randomly assigned 1,979 eligible men with stage T1b to T2b prostate adenocarcinoma and a PSA of 20 or less to radiotherapy alone (992) or radiotherapy with 4 months of total androgen suppression beginning 2 months before radiotherapy (987).\n\nAt a median 9.1 years, 10-year overall survival was 62 percent with combined treatment against 57 percent with radiotherapy alone, hazard ratio for death with radiotherapy alone 1.17, p=0.03. Ten-year disease-specific mortality fell from 8 to 4 percent, hazard ratio 1.87, p=0.001. Biochemical failure, distant metastases and positive repeat biopsy at 2 years all improved.\n\nThe post-hoc risk analysis is what changed practice: the reductions in overall and disease-specific mortality were concentrated in intermediate-risk men, with no significant reduction in low-risk men. That is why a man with low-risk disease having radiotherapy today is usually offered no hormone therapy at all, and a man with intermediate-risk disease is offered 4 to 6 months.\n\nToxicity was modest. Acute and late radiation effects were similar in the two groups and grade 3 or higher hormone-related effects occurred in under 5 percent.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00002597","url":"https://clinicaltrials.gov/study/NCT00002597"},{"label":"RTOG 94-08 (New England Journal of Medicine 2011)","url":"https://doi.org/10.1056/NEJMoa1012348"}],"tags":[],"related":[],"cancers":["prostate","prostate-low-risk","prostate-intermediate-risk"],"sections":[],"technologies":["androgen-deprivation","imrt-igrt"],"targets":[],"drugs":[],"companies":["nrg-oncology"],"institutions":[],"pathways":[],"terms":["adt","curative-intent","hormone-therapy"],"trials":["eortc-22991","rtog-9202","chhip"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00002597","phase":"3","setting":"Stage T1b, T1c, T2a or T2b prostate adenocarcinoma with PSA of 20 or less: radiotherapy alone against radiotherapy with 4 months of total androgen suppression starting 2 months before it, with overall survival as the primary endpoint","sponsor":"Radiation Therapy Oncology Group, now NRG Oncology, funded by the National Cancer Institute","result":"Ten-year overall survival 62 against 57 percent (hazard ratio for death with radiotherapy alone 1.17, p=0.03) and disease-specific mortality 4 against 8 percent; benefit confined to intermediate-risk men on post-hoc analysis.","yearReported":2011,"enrolled":1979,"enrolledBasis":"randomised","enrolledNote":"1,979 eligible men were randomly assigned between 1994 and 2001.","outcomes":[{"endpoint":"Overall survival at 10 years","primary":true,"unit":"%","arms":[{"name":"Radiotherapy with 4 months of androgen suppression","n":987,"value":62,"note":"Hazard ratio is for death with radiotherapy alone."},{"name":"Radiotherapy alone","n":992,"value":57}],"hr":1.17,"p":"0.03","source":"https://doi.org/10.1056/NEJMoa1012348"},{"endpoint":"Disease-specific mortality at 10 years","unit":"%","arms":[{"name":"Radiotherapy with 4 months of androgen suppression","n":987,"value":4},{"name":"Radiotherapy alone","n":992,"value":8}],"hr":1.87,"p":"0.001","source":"https://doi.org/10.1056/NEJMoa1012348"}],"replication":"EORTC 22991 found the same for 6 months of androgen suppression added to dose-escalated radiotherapy in 819 men, with a biochemical disease-free survival hazard ratio of 0.52."},"route":"/trials/rtog-9408/","neighbours":{"cancer":[{"id":"prostate-intermediate-risk","kind":"cancer","name":"Localised prostate cancer, intermediate risk","route":"/cancers/prostate-intermediate-risk/"},{"id":"prostate-low-risk","kind":"cancer","name":"Localised prostate cancer, very low and low risk","route":"/cancers/prostate-low-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":"nrg-oncology","kind":"company","name":"NRG Oncology","route":"/companies/nrg-oncology/"}],"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/"}],"trial":[{"id":"chhip","kind":"trial","name":"CHHiP","route":"/trials/chhip/"},{"id":"eortc-22991","kind":"trial","name":"EORTC 22991","route":"/trials/eortc-22991/"},{"id":"rtog-9202","kind":"trial","name":"RTOG 92-02","route":"/trials/rtog-9202/"}]}}