摘要：

The clinical course of patients originally part of a large scale randomized prospective clinical trial of treatment for cancer of the prostate who were later taken off-study and given additional therapy is described. Because of the selective biases involved it is not possible to make precise statistical comparisons of the effects of secondary treatment. However, a detailed analysis of the data for these patients has led to several important observations and inferences. 1. (1) Patients whose initial treatment was placebo were more likely to be taken offstudy, were taken off-study when they were in comparatively better health than patients on the other treatments, and survived longer after going off-study. 2. (2) Patients whose original treatment was placebo were more likely to benefit from secondary treatment. 3. (3) There was no evidence in these data that the treatment with estrogen in the late stages of cancer of the prostate was associated with increased risk of death due to cardiovascular causes. 4. (4) A decrease in the acid phosphatase could occur late in the course of the disease if therapy was changed even if the initial therapy included estrogen or orchiectomy or both. 5. (5) The results of this analysis are consistent with the philosophy that hormonal treatment or orchiectomy for cancer of the prostate should be withheld until it is required for relief of symptoms. Confirmation of the observations and inferences arising from this study must await appropriate controlled trials designed specifically to test them.

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