PROSTATE CANCER CHEMOPREVENTION CLINICAL TRIALS

描述：（申请人的描述）本申请的总体目标 项目是（1）开发前列腺癌的化学预防方法， (2)开发一种实用的方法来检测前列腺癌 临床试验中的化学预防功效。 申请人建议， 首先测试化学预防剂降低 前列腺特异性抗原（PSA）水平升高的男性作为第一个 前列腺癌根治性切除术后复发征象 双盲随机试验 随后，研究者将在 一项双盲、随机试验， 在这方面的活性，以延缓前列腺根治性切除术后复发 前列腺切除术（使用超敏感PSA测定PSA失败） 检测）在男性中，这是在高风险。 与此同时，他还将 确定这些药剂是否降低发生频率和/或 循环前列腺癌细胞的数量，如通过高度 检测前列腺特异性膜mRNA的灵敏RT-PCR方法 抗原（PSM）由这些细胞产生;这是一个潜在的标志物， 转移性前列腺癌的风险。 大豆蛋白和 脱氢表雄酮（DHEA）已被选为两种药物， 在这个项目中测试它们的癌症化学预防功效。 如果 在所希望的方向上的实质性效果被发现在拟议的 研究，为未来的男性预防临床试验奠定了基础， 发展为临床上明显的前列腺癌的高风险。

Description: (Applicant s Description) The overall objectives of this project are (1) to develop a chemoprevention method for prostate cancer and (2) to develop a practical approach for testing prostate cancer chemoprevention efficacy in clinical trials. The applicant proposes as general approach to first test the ability of chemopreventive agents reduce prostate-specific antigen (PSA) levels in men with rising PSA as the first sign of Recurrent prostate cancer following radical prostatectomy in a double-blind, randomized trial. Subsequently, the investigator will test in a double-blind, randomized trial the ability of the agent(s) that is/are active in this respect to delay prostate recurrence following radical prostatectomy (as measured by PSA failure using an ultra sensitive PSA assay) in men that are at high risk for this. In parallel, he will also determine whether these agents reduce the frequency of occurrence and/or quantity of circulating prostate cancer cells, as measured by a highly sensitive RT-PCR method that detects mRNA for prostate-specific membrane antigen (PSM) produced by these cells; this is a potential marker for the risk of progression to metastatic prostate cancer. Soy protein and dehydroepiandrosterone (DHEA) have been selected as the two agents that will be tested in this project for their cancer chemoprevention efficacy. If substantive effects in the desired direction are found in the proposed studies, the stage is set for future prevention clinical trials in men at high risk for developing clinically evident prostate cancer.