{"entity":{"id":"radicals-rt","kind":"trial","name":"RADICALS-RT","aka":["RADICALS-RT","RADICALS radiotherapy timing comparison"],"tldr":"Waiting to see whether the PSA rises after prostate surgery, and only then giving radiotherapy, works as well as treating everybody straight away, and spares two men in three the radiotherapy altogether.","summary":"RADICALS-RT randomised 1,396 men in trial-accredited centres in Canada, Denmark, Ireland and the United Kingdom, 697 to adjuvant radiotherapy and 699 to an observation policy with salvage radiotherapy for PSA biochemical progression. Median age was 65. The trial was powered on freedom from distant metastases, designed to detect a rise from 90 percent with salvage to 95 percent at 10 years.\n\nAt a median 4.9 years, 649 of 697 men allocated adjuvant radiotherapy (93 percent) had it within 6 months, while only 228 of 699 (33 percent) in the observation group had radiotherapy within 8 years. That single number is the practical result: two men in three were spared pelvic radiotherapy.\n\nWith 169 events, 5-year biochemical progression-free survival was 85 percent with adjuvant and 88 percent with salvage radiotherapy, hazard ratio 1.10 (95 percent confidence interval 0.81 to 1.49, p=0.56). Freedom from non-protocol hormone therapy at 5 years was 93 against 92 percent, hazard ratio 0.88 (0.58 to 1.33, p=0.53).\n\nThe harm was measurable and one-sided. Self-reported urinary incontinence was worse at 1 year after adjuvant radiotherapy (mean score 4.8 against 4.0, p=0.0023), and grade 3 to 4 urethral stricture within 2 years occurred in 6 percent against 4 percent (p=0.020). The conclusion, that an observation policy with salvage radiotherapy should be the standard, is now written into practice.","status":"negative","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-RT (Lancet 2020)","url":"https://doi.org/10.1016/S0140-6736(20)31553-1"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk","prostate-bcr"],"sections":[],"technologies":["imrt-igrt"],"targets":[],"drugs":[],"companies":["mrc-ctu"],"institutions":["uclh"],"pathways":[],"terms":["prostatectomy","salvage-therapy","biochemical-recurrence","neoadjuvant-adjuvant","qol-pro"],"trials":["raves","getug-afu-17","artistic-meta-analysis","radicals-hd","swog-8794","eortc-22911"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00541047","phase":"3","setting":"Prostate cancer after radical prostatectomy with at least one risk factor, being pathological T3 or T4, Gleason 7 to 10, positive margins or preoperative PSA of 10 or more: adjuvant radiotherapy against an observation policy with salvage radiotherapy triggered by a PSA of 0.1 or more or three consecutive rises, with freedom from distant metastases as the primary outcome","sponsor":"MRC Clinical Trials Unit at UCL, funded by Cancer Research UK, the MRC and the Canadian Cancer Society","result":"Five-year biochemical progression-free survival 85 percent with adjuvant against 88 percent with early salvage radiotherapy (hazard ratio 1.10, 95 percent confidence interval 0.81 to 1.49); only 33 percent of the observation group needed radiotherapy within 8 years, and adjuvant treatment caused more incontinence and urethral stricture.","yearReported":2020,"enrolled":1396,"enrolledBasis":"randomised","enrolledNote":"1,396 men were randomised to the radiotherapy timing comparison; NCT00541047 also covers the separate RADICALS-HD hormone duration randomisation, so the registry figure is larger.","outcomes":[{"endpoint":"Biochemical progression-free survival at 5 years","unit":"%","arms":[{"name":"Adjuvant radiotherapy","n":697,"value":85},{"name":"Observation with salvage radiotherapy","n":699,"value":88}],"hr":1.1,"ci":[0.81,1.49],"p":"0.56","source":"https://doi.org/10.1016/S0140-6736(20)31553-1"},{"endpoint":"Grade 3 to 4 urethral stricture within 2 years","unit":"%","arms":[{"name":"Adjuvant radiotherapy","n":697,"value":6},{"name":"Observation with salvage radiotherapy","n":699,"value":4}],"p":"0.020","source":"https://doi.org/10.1016/S0140-6736(20)31553-1"}],"replication":"RAVES (333 men) and GETUG-AFU 17 (424 men) found the same, and the prospectively planned ARTISTIC meta-analysis of all three trials (2,153 men) found an event-free survival hazard ratio of 0.95 (0.75 to 1.21)."},"route":"/trials/radicals-rt/","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":"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":"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":"qol-pro","kind":"term","name":"Quality of life and patient-reported outcomes (QoL, PRO)","route":"/terms/qol-pro/"},{"id":"prostatectomy","kind":"term","name":"Radical prostatectomy","route":"/terms/prostatectomy/"},{"id":"salvage-therapy","kind":"term","name":"Salvage therapy","route":"/terms/salvage-therapy/"}],"trial":[{"id":"artistic-meta-analysis","kind":"trial","name":"ARTISTIC meta-analysis","route":"/trials/artistic-meta-analysis/"},{"id":"eortc-22911","kind":"trial","name":"EORTC 22911","route":"/trials/eortc-22911/"},{"id":"getug-afu-17","kind":"trial","name":"GETUG-AFU 17","route":"/trials/getug-afu-17/"},{"id":"radicals-hd","kind":"trial","name":"RADICALS-HD","route":"/trials/radicals-hd/"},{"id":"raves","kind":"trial","name":"RAVES (TROG 08.03/ANZUP)","route":"/trials/raves/"},{"id":"swog-8794","kind":"trial","name":"SWOG 8794","route":"/trials/swog-8794/"}]}}