{"entity":{"id":"rtog-9601","kind":"trial","name":"RTOG 9601","aka":[],"tldr":"RTOG 9601 showed that adding two years of hormone therapy to salvage radiotherapy after prostate surgery lengthens survival, mainly in men with higher PSA levels at relapse.","summary":"RTOG 9601 randomised 760 men with a rising PSA after radical prostatectomy to salvage radiotherapy (64.8 Gy) with 24 months of bicalutamide 150 mg or placebo. Twelve-year overall survival was 76.3 percent with bicalutamide and 71.3 percent with placebo (hazard ratio 0.77), with fewer prostate cancer deaths and metastases; the benefit was concentrated in men with PSA above 0.7 ng/mL, and gynaecomastia was common (Shipley and colleagues, New England Journal of Medicine 2017).","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00002874","url":"https://clinicaltrials.gov/study/NCT00002874"},{"label":"NEJM 2017","url":"https://doi.org/10.1056/NEJMoa1607529"}],"tags":["radiation-wave4"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":["bicalutamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"notes":[],"nct":"NCT00002874","phase":"3","setting":"Rising PSA after prostatectomy: salvage radiotherapy with two years of bicalutamide versus salvage radiotherapy with placebo","sponsor":"Radiation Therapy Oncology Group","result":"12-year overall survival 76.3% vs 71.3% (hazard ratio 0.77); benefit mainly with PSA above 0.7 ng/mL.","yearReported":2017,"enrolled":760,"outcomes":[{"endpoint":"Overall survival at 12 years","primary":true,"unit":"%","arms":[{"name":"Salvage radiotherapy plus bicalutamide","n":384,"value":76.3},{"name":"Salvage radiotherapy plus placebo","n":376,"value":71.3}]}]},"route":"/trials/rtog-9601/","neighbours":{"cancer":[{"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/"}],"drug":[{"id":"bicalutamide","kind":"drug","name":"Bicalutamide","route":"/drugs/bicalutamide/"}]}}