{"entity":{"id":"paper-gravis-getug-afu-15-docetaxel-lancet-oncol-2013","kind":"paper","name":"GETUG-AFU 15: androgen deprivation alone or with docetaxel in non-castrate metastatic prostate cancer","aka":["GETUG-AFU 15","GETUG 15","Gravis 2013 docetaxel hormone-sensitive"],"tldr":"The first trial to give chemotherapy at the same time as hormone therapy in newly diagnosed metastatic prostate cancer. It found no survival benefit and concluded against the approach, two years before two larger trials found the opposite.","summary":"Gwenaelle Gravis and the French GETUG-AFU group randomised 385 men with metastatic non-castrate prostate cancer to androgen deprivation alone or with up to nine cycles of docetaxel, between 2004 and 2008. Median follow-up was 50 months and the primary endpoint was overall survival.\n\nThe trial is in this roadmap because of what happened next. Its conclusion, printed in the abstract, was that docetaxel should not be used as part of first-line treatment. CHAARTED in 2015 and STAMPEDE in 2016 then reported the opposite, in larger populations with more high-volume disease, and the STOpCaP meta-analysis in 2016 resolved the three by pooling them. GETUG-AFU 15 is the clearest case in prostate cancer of a trial that was underpowered for the population in which the effect actually lives, and it is why the volume-of-disease subgroup became part of how the field thinks.","asOf":"2026-09-25","links":[{"label":"Lancet Oncol 2013","url":"https://doi.org/10.1016/s1470-2045(12)70560-0"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/23306100/"},{"label":"ClinicalTrials.gov NCT00104715","url":"https://clinicaltrials.gov/study/NCT00104715"}],"tags":["prostate-evidence"],"related":["paper-chaarted-nejm-2015","paper-stampede-lancet-2016","paper-vale-stopcap-docetaxel-bisphosphonates-lancet-oncol-2016","prostate-roadmap"],"cancers":["prostate","prostate-mhspc"],"sections":["chemotherapy","hormonal"],"technologies":[],"targets":[],"drugs":["docetaxel"],"companies":[],"institutions":[],"pathways":[],"terms":["adt","hazard-ratio"],"trials":[],"people":["karim-fizazi"],"bottlenecks":["b-trial-design","b-negative-results","b-trial-enrolment"],"keyPapers":[],"journals":["lancet-oncology"],"dependsOn":[],"notes":[],"journal":"The Lancet Oncology","year":2013,"doi":"10.1016/s1470-2045(12)70560-0","pmid":"23306100","authors":"Gravis G, Fizazi K, Joly F, et al.","paperType":"rct","findings":["Median overall survival 58.9 months (95 percent confidence interval 50.8 to 69.1) with androgen deprivation plus docetaxel against 54.2 months (42.2 to not reached) with androgen deprivation alone; hazard ratio 1.01 (0.75 to 1.36).","72 serious adverse events in the docetaxel group, most frequently neutropenia in 40 patients (21 percent) and febrile neutropenia in 6 (3 percent).","Four treatment-related deaths occurred in the docetaxel group, two of them neutropenia-related, after which the data monitoring committee recommended granulocyte colony-stimulating factor; no further treatment-related deaths followed.","No serious adverse events were reported in the androgen deprivation alone group.","The published interpretation was that docetaxel should not be used as part of first-line treatment for non-castrate metastatic prostate cancer."],"whatItMeans":"A negative trial that was later overturned, and a standing argument for pooling individual trials rather than acting on the first one to report. It is also the reason the distinction between high-volume and low-volume metastatic disease is written into guidelines.","caveats":["385 patients, which is small for an overall survival endpoint in a disease with a median survival near five years.","Enrolment ran from 2004 to 2008, before prostate-specific membrane antigen imaging, so disease volume was classified on bone scan and computed tomography.","The trial included a higher proportion of low-volume disease than CHAARTED, which is the most likely explanation for the difference in result."],"changedPractice":true,"participants":385},"route":"/key-papers/paper-gravis-getug-afu-15-docetaxel-lancet-oncol-2013/","neighbours":{"paper":[{"id":"paper-stampede-lancet-2016","kind":"paper","name":"Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial","route":"/key-papers/paper-stampede-lancet-2016/"},{"id":"paper-chaarted-nejm-2015","kind":"paper","name":"CHAARTED: chemohormonal therapy in metastatic hormone-sensitive prostate cancer","route":"/key-papers/paper-chaarted-nejm-2015/"},{"id":"paper-vale-stopcap-docetaxel-bisphosphonates-lancet-oncol-2016","kind":"paper","name":"STOpCaP: docetaxel or bisphosphonates added to standard of care in hormone-sensitive prostate cancer, a systematic review and meta-analysis","route":"/key-papers/paper-vale-stopcap-docetaxel-bisphosphonates-lancet-oncol-2016/"}],"roadmap":[{"id":"prostate-roadmap","kind":"roadmap","name":"Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch","route":"/roadmaps/prostate-roadmap/"}],"cancer":[{"id":"prostate-mhspc","kind":"cancer","name":"Metastatic hormone-sensitive prostate cancer","route":"/cancers/prostate-mhspc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"section":[{"id":"chemotherapy","kind":"section","name":"Chemotherapy","route":"/fronts/chemotherapy/"},{"id":"hormonal","kind":"section","name":"Hormonal Therapy","route":"/fronts/hormonal/"}],"drug":[{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"}],"term":[{"id":"adt","kind":"term","name":"Androgen deprivation therapy (ADT)","route":"/terms/adt/"},{"id":"hazard-ratio","kind":"term","name":"Hazard ratio (HR)","route":"/terms/hazard-ratio/"}],"person":[{"id":"karim-fizazi","kind":"person","name":"Karim Fizazi","route":"/people/karim-fizazi/"}],"bottleneck":[{"id":"b-negative-results","kind":"bottleneck","name":"Failures are hidden","route":"/bottlenecks/b-negative-results/"},{"id":"b-trial-design","kind":"bottleneck","name":"Trial design, endpoints and cost","route":"/bottlenecks/b-trial-design/"},{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"}],"journal":[{"id":"lancet-oncology","kind":"journal","name":"The Lancet Oncology","route":"/journals/lancet-oncology/"}]}}