Randomized clinical trials assessing novel therapies in men with localized prostate cancer frequently require large patient numbers and more than a decade of follow-up to demonstrate improvements in overall survival. As the landscape of treatment options for prostate cancer is rapidly changing, clinical trials requiring long follow-up threaten to impede treatment improvements and run the risk of results being obsolete by the time that they are reported in publication. To address these issues, there has been tremendous interest in identifying an intermediate clinical endpoint that can be assessed earlier in the disease course to serve as a robust surrogate for overall survival in men with localized prostate cancer. Herein we review the relevant data for surrogate endpoints in localized prostate cancer, highlighting the work performed by the Intermediate Clinical Endpoints in Cancer of the Prostate Working Group identifying metastasis-free survival as a valid surrogate for men treated for localized prostate cancer.

中文翻译：

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局部前列腺癌的替代终点。

评估局部前列腺癌男性新疗法的随机临床试验通常需要大量患者，并且需要十多年的随访才能证明总体生存率有所提高。随着前列腺癌治疗方案的格局在迅速变化，需要长期随访的临床试验可能会威胁到治疗方法的改进，并有可能导致结果在发表时被淘汰。为了解决这些问题，人们对确定一个可以在疾病过程中较早评估的中间临床终点具有极大的兴趣，该终点可以作为局部前列腺癌男性总体生存的有力替代物。在此，我们回顾了局部前列腺癌的替代终点的相关数据，