{"entity":{"id":"getug-afu-17","kind":"trial","name":"GETUG-AFU 17","aka":["GETUG-AFU 17","GETUG 17"],"tldr":"The French version of the same question, and the same answer: treating everyone straight after surgery does not help, and it doubles the rate of lasting bladder and erection problems.","summary":"GETUG-AFU 17 enrolled 424 men at 46 French hospitals with pT3a, pT3b or pT4a disease and positive surgical margins after radical prostatectomy, randomised 1:1 to immediate adjuvant radiotherapy or delayed salvage radiotherapy at biochemical relapse. All men received 6 months of triptorelin. Enrolment was stopped early on the recommendation of the independent data monitoring committee because event rates were unexpectedly low; 718 had been planned.\n\nAt a median 75 months, 205 of 212 men (97 percent) in the adjuvant group started treatment, against 115 of 212 (54 percent) in the salvage group. Five-year event-free survival was 92 percent (95 percent confidence interval 86 to 95) with adjuvant radiotherapy and 90 percent (85 to 94) with salvage, hazard ratio 0.81 (0.48 to 1.36, log-rank p=0.42).\n\nThe toxicity difference was large. Late grade 2 or worse genitourinary adverse events occurred in 58 of 212 men (27 percent) after adjuvant radiotherapy against 14 of 212 (7 percent) after salvage (p<0.0001), and late erectile dysfunction of grade 2 or worse in 60 of 212 (28 percent) against 17 of 212 (8 percent) (p<0.0001). Acute grade 3 or worse effects were rare in both arms, six and four men respectively.\n\nThe authors were candid that the analysis lacked statistical power, which is why the ARTISTIC meta-analysis was designed in advance to pool the three trials.","status":"mixed","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00667069","url":"https://clinicaltrials.gov/study/NCT00667069"},{"label":"GETUG-AFU 17 (Lancet Oncology 2020)","url":"https://doi.org/10.1016/S1470-2045(20)30454-X"}],"tags":[],"related":[],"cancers":["prostate","prostate-high-risk","prostate-bcr"],"sections":[],"technologies":["imrt-igrt","androgen-deprivation"],"targets":[],"drugs":["triptorelin"],"companies":["unicancer","ipsen"],"institutions":[],"pathways":[],"terms":["prostatectomy","salvage-therapy","biochemical-recurrence","qol-pro"],"trials":["radicals-rt","raves","artistic-meta-analysis"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00667069","phase":"3","setting":"pT3a, pT3b or pT4a prostate cancer with positive surgical margins after radical prostatectomy: immediate adjuvant radiotherapy against delayed salvage radiotherapy at biochemical relapse, both with 6 months of triptorelin, with event-free survival as the primary endpoint","sponsor":"UNICANCER, funded by the French Health Ministry and Ipsen","result":"Five-year event-free survival 92 percent with adjuvant against 90 percent with salvage radiotherapy (hazard ratio 0.81, 95 percent confidence interval 0.48 to 1.36); late grade 2 or worse genitourinary toxicity 27 against 7 percent and erectile dysfunction 28 against 8 percent.","yearReported":2020,"enrolled":424,"enrolledBasis":"randomised","enrolledNote":"424 of a planned 718 men were enrolled before the independent data monitoring committee recommended early termination because event rates were unexpectedly low.","outcomes":[{"endpoint":"Event-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"Adjuvant radiotherapy","n":212,"value":92},{"name":"Delayed salvage radiotherapy","n":212,"value":90}],"hr":0.81,"ci":[0.48,1.36],"p":"0.42","source":"https://doi.org/10.1016/S1470-2045(20)30454-X"},{"endpoint":"Late grade 2 or worse erectile dysfunction","unit":"%","arms":[{"name":"Adjuvant radiotherapy","n":212,"value":28},{"name":"Delayed salvage radiotherapy","n":212,"value":8}],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(20)30454-X"}],"replication":"RADICALS-RT and RAVES found the same, and all three were pooled in ARTISTIC."},"route":"/trials/getug-afu-17/","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":"triptorelin","kind":"drug","name":"Triptorelin","route":"/drugs/triptorelin/"}],"company":[{"id":"ipsen","kind":"company","name":"Ipsen","route":"/companies/ipsen/"},{"id":"unicancer","kind":"company","name":"UNICANCER","route":"/companies/unicancer/"}],"term":[{"id":"biochemical-recurrence","kind":"term","name":"Biochemical recurrence (BCR)","route":"/terms/biochemical-recurrence/"},{"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":"radicals-rt","kind":"trial","name":"RADICALS-RT","route":"/trials/radicals-rt/"},{"id":"raves","kind":"trial","name":"RAVES (TROG 08.03/ANZUP)","route":"/trials/raves/"}]}}