A clinical trial to determine the optimal timing of androgen deprivation in relapsed or non-curable prostate cancer

这项研究的目的是澄清什么时候是开始激素治疗前列腺癌的某些阶段的男性的最佳时间。长期以来，人们都知道睾丸激素的去除会阻碍前列腺癌的生长，尽管不是永久性的。然而，睾丸激素的去除有副作用，包括性欲丧失，潮热，体重增加，以及长期的骨质疏松症，肌肉体积损失和精神变化，如记忆力丧失。因此，患者获得的任何益处都必须与这些副作用进行权衡。在无法治愈的情况下，这一点尤其重要，因为治疗的目的应该是控制症状（通过预防或延迟症状或在症状出现时进行治疗）。有两种情况下，一个人可能被诊断为患有活动性前列腺癌，但没有需要立即治疗的症状。第一种是治愈性治疗失败后，通过血液中存在前列腺特异性抗原（PSA）显示，但没有任何其他前列腺癌的证据。第二种是新诊断出患有无症状前列腺癌的男性，但由于其他原因（如心脏病）而不适合尝试治疗。我们不知道在这两种情况下，如果立即开始治疗，男性是否会活得更长，或者等到症状出现是否合理，从而可能推迟治疗的副作用。因此，试验将包括这两组男性。一半的男性将随机接受立即治疗，另一半在症状出现或有进展性疾病证据时开始治疗。主要终点是总生存期，与生活质量和疾病和治疗的副作用相平衡。假设早期治疗将改善生存率，对生活质量的影响可接受。

The aim of the study is to clarify when is the optimal time to start hormone treatment for men with certain stages of prostate cancer. It has long been known that testosterone removal impedes prostate cancer growth, although not permanently. The removal of testosterone, however, has side effects , including loss of libido, hot flushes, weight gain, and in the longer term osteoporosis, loss of muscle bulk and mental changes such as loss of memory. Any benefit to be gained for a patient must therefore be weighed against these side effects. This is particularly relevant in situations in which cure is not possible, when the aim of treatment should be to manage symptoms (either by preventing or delaying them or treating them as they arise). There are two situations in which a man may be diagnosed as having active prostate cancer but be without symptoms requiring immediate treatment. The first is after the failure of curative treatment, shown by the presence of prostate specific antigen (PSA) in the blood, but without any other evidence of prostate cancer. The second is a man newly diagnosed with asymptomatic prostate cancer, but with other reasons (such as heart disease) which make an attempt at cure inappropriate. We do not know in either case whether or not men live longer if treatment is started immediately, or whether it is reasonable to wait until symptoms develop, thus potentially postponing the side effects of treatment. The trial will therefore include these two groups of men. Half the men will be randomised to receive immediate treatment, and half to treatment starting when symptoms develop, or when there is evidence of progressive disease. The main endpoint is overall survival, balanced against quality of life and side effects from the disease and treatment. The hypothesis is that early treatment will improve survival with acceptable effects on quality of life.