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Hormone therapy causes hot flushes, loss of libido, loss of muscle and bone, and low mood. This trial asked whether men could take breaks from it. After ten years the answer was uncomfortable: the breaks felt better for three months, and the trial could not rule out a worse chance of survival.
Maha Hussain and the Southwest Oncology Group enrolled 3,040 men with newly diagnosed metastatic hormone-sensitive prostate cancer, gave them seven months of androgen deprivation, and randomised the 1,535 whose prostate-specific antigen fell to 4 ng per millilitre or lower to continuous or intermittent therapy. The co-primary objectives were non-inferiority of survival, with an upper boundary on the hazard ratio of 1.20, and quality of life at three months.
The result is one of the most honestly reported inconclusive trials in oncology. Median survival was 5.8 years on continuous therapy and 5.1 years on intermittent, with a hazard ratio of 1.10 and a 90 percent confidence interval running to 1.23, which crosses the non-inferiority boundary without demonstrating inferiority either. Erectile function and mental health were better on intermittent therapy at month 3 and not afterwards.
The reason intermittent androgen deprivation is offered as a choice in metastatic disease rather than recommended, and a case study in what an inconclusive non-inferiority trial should say. For a man weighing the side effects, the honest statement is that the quality-of-life gain is real but brief and the survival question is open.
Shares TRANSFORMER: bipolar androgen therapy versus enzalutamide in asymptomatic metastatic castration-resistant prostate cancer, Intermittent androgen deprivation (IAD), Quality of life, PSA (prostate-specific antigen) and the tag prostate-evidence.
Shares Transdermal oestradiol for androgen suppression in prostate cancer: long-term cardiovascular outcomes from the randomised Prostate Adenocarcinoma Transcutaneous Hormone (PATCH) trial programme, 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 and the tag prostate-evidence.
Shares Other-cause mortality, Quality of life, PSA (prostate-specific antigen), 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 Other-cause mortality, Report death from other causes as an outcome of the prostate cancer service, split by deprivation and ethnicity, Hazard ratio (HR), Survivorship and late effects are neglected and the tag prostate-evidence.
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 Quality of life, PSA (prostate-specific antigen), 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 and the tag prostate-evidence.
Shares Other-cause mortality, Report death from other causes as an outcome of the prostate cancer service, split by deprivation and ethnicity, Quality of life, PSA (prostate-specific antigen) and the tag prostate-evidence.
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.