{"entity":{"id":"getug-afu-16","kind":"trial","name":"GETUG-AFU 16","aka":["GETUG-AFU 16","GETUG 16"],"tldr":"Adding six months of hormone therapy to radiotherapy given for a rising PSA after prostate surgery raised the proportion free of progression at ten years from about half to about two thirds.","summary":"GETUG-AFU 16 randomised 743 men whose PSA had risen from 0.1 to between 0.2 and 2.0 ng/mL after radical prostatectomy to salvage radiotherapy alone or salvage radiotherapy with short-term androgen suppression, given as 10.8 mg subcutaneous goserelin on the first day of irradiation and 3 months later. Radiotherapy was 66 Gy in 33 fractions, five days a week for 7 weeks, by three-dimensional conformal or intensity-modulated technique.\n\nAt the March 2019 cutoff, median follow-up 112 months, 120-month progression-free survival was 64 percent (95 percent confidence interval 58 to 69) with radiotherapy plus goserelin and 49 percent (43 to 54) with radiotherapy alone, hazard ratio 0.54 (0.43 to 0.68, stratified log-rank p<0.0001). Two secondary cancers occurred after the primary analysis and neither was considered treatment related. There were no treatment-related deaths.\n\nThe trial answers a narrow and practical question. It does not tell a man whether 6 months is the right duration, which RADICALS-HD addressed with a 6 against 24 month comparison, nor whether the pelvic nodes should be treated, which SPPORT addressed.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT00423475","url":"https://clinicaltrials.gov/study/NCT00423475"},{"label":"GETUG-AFU 16 at 112 months (Lancet Oncology 2019)","url":"https://doi.org/10.1016/S1470-2045(19)30486-3"}],"tags":[],"related":[],"cancers":["prostate","prostate-bcr"],"sections":[],"technologies":["androgen-deprivation","imrt-igrt"],"targets":[],"drugs":["goserelin"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":["adt","salvage-therapy","biochemical-recurrence","prostatectomy"],"trials":["rtog-9601","nct00567580","radicals-hd"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00423475","phase":"3","setting":"Rising PSA between 0.2 and 2.0 ng/mL after radical prostatectomy for pT2, pT3 or pT4a pN0 or pNx disease, without previous androgen suppression or pelvic radiotherapy: salvage radiotherapy of 66 Gy in 33 fractions alone against the same with 6 months of goserelin, with progression-free survival as the primary endpoint","sponsor":"UNICANCER, funded by the French Health Ministry, AstraZeneca and la Ligue Contre le Cancer","result":"Progression-free survival at 120 months 64 percent with salvage radiotherapy plus 6 months of goserelin against 49 percent with radiotherapy alone (hazard ratio 0.54, 95 percent confidence interval 0.43 to 0.68).","yearReported":2019,"enrolled":743,"enrolledBasis":"randomised","enrolledNote":"743 men were randomly assigned between October 2006 and March 2010, 374 to radiotherapy alone and 369 to radiotherapy with goserelin.","outcomes":[{"endpoint":"Progression-free survival at 120 months","primary":true,"unit":"%","arms":[{"name":"Salvage radiotherapy with 6 months of goserelin","n":369,"value":64},{"name":"Salvage radiotherapy alone","n":374,"value":49}],"hr":0.54,"ci":[0.43,0.68],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(19)30486-3"}],"replication":"RTOG 9601 showed the same direction with 24 months of bicalutamide, and SPPORT with 4 to 6 months of androgen deprivation with or without pelvic nodal radiotherapy."},"route":"/trials/getug-afu-16/","neighbours":{"cancer":[{"id":"prostate-bcr","kind":"cancer","name":"Biochemical recurrence of prostate cancer","route":"/cancers/prostate-bcr/"},{"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":"goserelin","kind":"drug","name":"Goserelin / leuprolide (ovarian function suppression)","route":"/drugs/goserelin/"}],"company":[{"id":"unicancer","kind":"company","name":"UNICANCER","route":"/companies/unicancer/"}],"term":[{"id":"adt","kind":"term","name":"Androgen deprivation therapy (ADT)","route":"/terms/adt/"},{"id":"biochemical-recurrence","kind":"term","name":"Biochemical recurrence (BCR)","route":"/terms/biochemical-recurrence/"},{"id":"prostatectomy","kind":"term","name":"Radical prostatectomy","route":"/terms/prostatectomy/"},{"id":"salvage-therapy","kind":"term","name":"Salvage therapy","route":"/terms/salvage-therapy/"}],"trial":[{"id":"embark","kind":"trial","name":"EMBARK","route":"/trials/embark/"},{"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-hd","kind":"trial","name":"RADICALS-HD","route":"/trials/radicals-hd/"},{"id":"rtog-9601","kind":"trial","name":"RTOG 9601","route":"/trials/rtog-9601/"}]}}