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Clinical Models for Testing Chemopreventative Agents in Prostate Cancer and Overview of SELECT: The Selenium and Vitamin E Cancer Prevention Trial

机译:用于测试前列腺癌中化学预防剂的临床模型及选择:硒和维生素E癌预防试验

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Target populations for chemoprevention trials should include those at higher than average risk for the development of prostate cancer as defined by explicit epidemiologic and genetic criteria. Such populations include a "primary prevention" group without histologic or clinical evidence of cancer, and several clinical models of "secondary prevention" including those with clinically evident disease prior to definitive therapy and those at high risk of recurrence after therapy based on histology and/or biochemical status. Each risk group and clinical model has potential advantages and disadvantages, and the mechanisms which underlie disease development and progression in each group may be unique. These observations give rise to many potential clinical trials of specific agents. These trials should also include collection of data on potentially confounding influences on disease development and progression. Precli-nical, epidemiologic, and Phase II data suggest that both selenium and vitamin E have potentialefficacy in prostate cancer prevention. The experience of the Prostate Cancer Prevention Trial (PCPT) demonstrates the interest and dedication of healthy men to long-term studies of cancer prevention. SELECT, the Selenium and Vitamin E Cancer Prevention Trial, is an intergroup phase III, randomized, double-blind, placebo-controlled, population-based clinical trial designed to test the efficacy of selenium and vitamin E alone and in combination in the prevention of prostate cancer which builds on secondary analyses of large-scale chemoprevention trials for other cancers and the lessons of PCPT.
机译:化学普化试验的目标群体应包括由明确的流行病学和遗传标准所定义的前列腺癌发展的高于平均风险。这种群体包括没有癌症组织学或临床证据的“初级预防”组,以及在明确治疗之前的“二级预防”的临床模型,包括临床明显疾病,并且基于组织学和/ / /或生物化学地位。每个风险组和临床模型都具有潜在的优缺点,并且疾病发展和每组的进展的机制可能是独一无二的。这些观察结果产生了许多特定药剂的临床试验。这些试验还应包括关于对疾病发展和进展的潜在混淆影响的数据。 precli-nical,流行病学和第II期数据表明,硒和维生素E都具有前列腺癌预防患者的潜能性。前列腺癌预防试验(PCPT)的经验表明了健康男性对癌症预防长期研究的兴趣和奉献。选择,硒和维生素E癌症预防试验,是一种互动期III,随机,双盲,安慰剂控制,旨在单独测试硒和维生素E单独测试硒和维生素E的疗效和预防前列腺癌建立在其他癌症和PCPT的课程的大规模化学预防试验中的二次分析。

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