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

这项研究的目的是为了阐明，对于某些阶段的前列腺癌患者来说，何时是开始激素治疗的最佳时机。人们早就知道去除睾丸激素会阻碍前列腺癌的生长，尽管不是永久的。然而，去除睾丸激素会产生副作用，包括性欲减退、潮热、体重增加，长期来看，还会出现骨质疏松、肌肉萎缩和记忆力减退等心理变化。因此，对病人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）。在两种情况下，男性可能被诊断为活动性前列腺癌，但没有需要立即治疗的症状。第一种是在治疗失败后，表现为血液中存在前列腺特异性抗原（PSA），但没有其他前列腺癌的证据。第二种是新诊断为无症状前列腺癌的男性，但由于其他原因（如心脏病）使得尝试治疗不合适。在这两种情况下，我们都不知道如果立即开始治疗，男性是否会活得更长，或者等到症状出现后再治疗是否合理，从而可能推迟治疗的副作用。因此，审判将包括这两组人。一半的男性将被随机分配到立即接受治疗，另一半在症状出现或有证据表明疾病进展时开始治疗。主要终点是总体生存，平衡生活质量和疾病和治疗的副作用。其假设是，早期治疗将提高生存率，并对生活质量产生可接受的影响。

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.