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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.
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.
The 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.
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.
This is the paper Europe PMC returns for registry id NCT00268476 with the most citations, so it is the natural first reading for anyone following the STAMPEDE trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
The answer to a question three individual trials could not answer on their own, and the reason docetaxel with androgen deprivation became standard for metastatic hormone-sensitive disease. It also stopped a widely used bone drug being credited with a survival effect it does not have.
Docetaxel with androgen deprivation is a standard for high-volume metastatic hormone-sensitive prostate cancer, now usually combined with an androgen receptor pathway inhibitor as triplet therapy.
Shares Androgen deprivation therapy (ADT), Hazard ratio (HR), Metastatic hormone-sensitive prostate cancer, 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 and the tag prostate-evidence.
Shares CHAARTED: chemohormonal therapy in metastatic hormone-sensitive prostate cancer, Hazard ratio (HR), 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, Docetaxel and the tag prostate-evidence.
Shares Androgen deprivation therapy (ADT), Metastatic hormone-sensitive prostate cancer, 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, Prostate cancer and the tag prostate-evidence.
Shares Karim Fizazi, Trials enrol too few, too slowly, 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, Docetaxel and the tag prostate-evidence.
Shares Androgen deprivation therapy (ADT), 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, Prostate cancer and the tag prostate-evidence.
Shares Hazard ratio (HR), 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, Docetaxel, Prostate cancer and the tag prostate-evidence.
Shares Karim Fizazi, 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, Prostate cancer and the tag prostate-evidence.
Shares Androgen deprivation therapy (ADT), Metastatic hormone-sensitive prostate cancer, 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, Prostate cancer and the tag prostate-evidence.