{"entity":{"id":"radicals-hd","kind":"trial","name":"RADICALS-HD","aka":["RADICALS-HD","RADICALS hormone duration comparison"],"tldr":"Two years of hormone therapy alongside radiotherapy after prostate surgery kept the cancer from spreading in six more men in a hundred than six months did, at the cost of more side effects.","summary":"RADICALS-HD randomised 1,523 men, median age 65, at 138 centres in Canada, Denmark, Ireland and the United Kingdom to add 6 months of androgen deprivation (761) or 24 months (762) to postoperative radiotherapy. Androgen deprivation could be a monthly or 3-monthly gonadotrophin-releasing hormone analogue, daily oral bicalutamide 150 mg, or monthly subcutaneous degarelix. The comparison had over 80 percent power to detect an increase in 10-year metastasis-free survival from 75 to 81 percent.\n\nAt a median 8.9 years and 313 metastasis-free survival events, long-course treatment was better: 174 events on short-course against 139 on long-course, hazard ratio 0.773 (95 percent confidence interval 0.612 to 0.975, p=0.029). Ten-year metastasis-free survival was 71.9 percent (67.6 to 75.7) with 6 months and 78.1 percent (74.2 to 81.5) with 24 months.\n\nThe cost is stated plainly in the paper: grade 3 or higher toxicity in 105 of 753 men (14 percent) on short-course against 142 of 757 (19 percent) on long-course (p=0.025), with no treatment-related deaths. The authors framed the recommendation as conditional, for individuals who can accept the additional duration of adverse effects, which is the right way to put a 6 percentage point gain against eighteen extra months of castration.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00541047","url":"https://clinicaltrials.gov/study/NCT00541047"},{"label":"ISRCTN registry ISRCTN40814031","url":"https://www.isrctn.com/ISRCTN40814031"},{"label":"RADICALS-HD (Lancet 2024)","url":"https://doi.org/10.1016/S0140-6736(24)00549-X"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk","prostate-bcr"],"sections":[],"technologies":["androgen-deprivation","imrt-igrt"],"targets":[],"drugs":["bicalutamide","degarelix"],"companies":["mrc-ctu"],"institutions":["uclh"],"pathways":[],"terms":["adt","salvage-therapy","prostatectomy","hormone-therapy"],"trials":["radicals-rt","getug-afu-16","nct00567580"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN40814031","phase":"3","setting":"Postoperative radiotherapy after radical prostatectomy with a PSA below 5 and no metastatic disease: 6 months of androgen deprivation against 24 months, given as a gonadotrophin-releasing hormone analogue, bicalutamide 150 mg daily or degarelix, with metastasis-free survival as the primary outcome","sponsor":"MRC Clinical Trials Unit at UCL, funded by Cancer Research UK, UK Research and Innovation and the Canadian Cancer Society","result":"Ten-year metastasis-free survival 78.1 percent with 24 months of androgen deprivation against 71.9 percent with 6 months (hazard ratio 0.773, 95 percent confidence interval 0.612 to 0.975, p=0.029); grade 3 or higher toxicity 19 against 14 percent.","yearReported":2024,"enrolled":1523,"enrolledBasis":"randomised","enrolledNote":"1,523 men were randomised to the short-course against long-course hormone duration comparison at 138 centres; NCT00541047 also covers the separate RADICALS-RT timing randomisation, so the registry figure is larger.","outcomes":[{"endpoint":"Metastasis-free survival at 10 years","primary":true,"unit":"%","arms":[{"name":"Long-course androgen deprivation, 24 months","n":762,"value":78.1},{"name":"Short-course androgen deprivation, 6 months","n":761,"value":71.9}],"hr":0.773,"ci":[0.612,0.975],"p":"0.029","source":"https://doi.org/10.1016/S0140-6736(24)00549-X"},{"endpoint":"Grade 3 or higher toxicity","unit":"%","arms":[{"name":"Long-course androgen deprivation, 24 months","n":757,"value":19},{"name":"Short-course androgen deprivation, 6 months","n":753,"value":14}],"p":"0.025","source":"https://doi.org/10.1016/S0140-6736(24)00549-X"}],"replication":"Consistent in direction with GETUG-AFU 16, which showed that adding 6 months of goserelin to salvage radiotherapy improves progression-free survival, and with SPPORT, which added pelvic nodal radiotherapy on top."},"route":"/trials/radicals-hd/","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":"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/"}],"drug":[{"id":"bicalutamide","kind":"drug","name":"Bicalutamide","route":"/drugs/bicalutamide/"},{"id":"degarelix","kind":"drug","name":"Degarelix","route":"/drugs/degarelix/"}],"company":[{"id":"mrc-ctu","kind":"company","name":"MRC Clinical Trials Unit at UCL","route":"/companies/mrc-ctu/"}],"institution":[{"id":"uclh","kind":"institution","name":"University College London Hospitals / UCL Cancer Institute","route":"/institutions/uclh/"}],"term":[{"id":"adt","kind":"term","name":"Androgen deprivation therapy (ADT)","route":"/terms/adt/"},{"id":"hormone-therapy","kind":"term","name":"Hormone therapy","route":"/terms/hormone-therapy/"},{"id":"prostatectomy","kind":"term","name":"Radical prostatectomy","route":"/terms/prostatectomy/"},{"id":"salvage-therapy","kind":"term","name":"Salvage therapy","route":"/terms/salvage-therapy/"},{"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":"embark","kind":"trial","name":"EMBARK","route":"/trials/embark/"},{"id":"getug-afu-16","kind":"trial","name":"GETUG-AFU 16","route":"/trials/getug-afu-16/"},{"id":"nct00567580","kind":"trial","name":"Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer","route":"/trials/nct00567580/"},{"id":"radicals-rt","kind":"trial","name":"RADICALS-RT","route":"/trials/radicals-rt/"}]}}