PROSTATE CANCER CHEMOPREVENTION CLINICAL TRIALS

描述：(应聘者S描述)本次活动的总体目标 项目是(1)开发前列腺癌的化学预防方法和 (2)开发一种实用的前列腺癌检测方法 临床试验中的化学预防效果。申请人建议如下： 首先检验化学预防药剂减量能力的一般方法 以前列腺特异性抗原(PSA)升高为首发症状的男性 前列腺癌根治术后复发的征象 双盲随机试验。随后，调查员将在 一项关于代理人(S)能力的双盲随机试验 这方面的积极作用可以延缓前列腺癌根治术后的复发 前列腺切除术(通过使用超敏感的PSA检测PSA失败来衡量 化验)在患此病的高危人群中。同时，他还将 确定这些药物是否减少了发生的频率和/或 循环中的前列腺癌细胞的数量，通过高度的 检测前列腺特异性膜基因表达的灵敏RT-PCR方法 由这些细胞产生的抗原(PSM)；这是一个潜在的标志 进展为转移性前列腺癌的风险。大豆蛋白和 脱氢表雄酮(DHEA)已被选为两种将 在这个项目中测试他们的癌症化学预防效果。如果 在预期方向上的实质性影响在拟议的 研究，为未来在男性中进行预防临床试验奠定了基础 罹患临床明显前列腺癌的高风险。

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.