SELENIUM BASED CHEMOPREVENTION

我们建议评估男性前列腺癌的化学预防。 谁是凭借被诊断出患有高级别前列腺癌 前列腺癌高度升高的上皮内瘤变(HGPIN) 风险。在基于活检的HGPIN诊断后，每个受试者将重新进行 做了活组织检查，以最大限度地减少第一次活组织检查错过PC的可能性。 然后，受试者将被随机分配到200微克/天的 L的形式-硒蛋氨酸或匹配的安慰剂。在随机化之后， 每一位主考者将被跟踪三年。 本研究的主要终点是PC。次要终端将包括 两种已建立的替代终点生物标记物(SEB)：Ki-67对 细胞增殖和TUNEL法检测细胞凋亡。这其中的每一个 将评估终端的重复性、预测性关联 与随后的PC，以及对补硒的反应。在……里面 此外，我们建议对两个潜在的SEB进行开发调查 基于机器视觉的组织计量学：基底细胞的侵蚀 前列腺管和染色质图案的组织计量学特征。 将对这些发育的SEB进行重复性研究。

We propose to evaluate the chemoprevention of prostate cancer among men who are, by virtue of having been diagnosed with High Grade Prostatic Intraepithelial Neoplasia (HGPIN), at a greatly elevated prostate cancer risk. After a biopsy-based diagnosis of HGPIN, each subject will be re- biopsied to minimize the probability he has PC missed by the first biopsy. Subjects will then be randomized to either 200 mcg/day of selenium in the form of L-selenomethionine or to a matching placebo. After randomization, each subjective will be followed for three years. The primary endpoint of this study is PC. Secondary endpoints will include two established Surrogate Endpoint Biomarkers (SEBs): Ki-67 evaluation of cell proliferation and TUNEL evaluation of apoptosis. Each of these endpoints will be evaluated for reproducibility, predictive association with subsequent PC, and for response to selenium supplementation. In addition, we propose a developmental investigation of two potential SEBs that are based on machine vision histometry: erosion of the basal cells of prostatic ducts and histometric characteristics of chromatin patterns. These developmental SEBs will be investigated for reproducibility.