CLINICAL TRIAL: PHASE II STUDY TO ASSESS RADIATION AND DOCETAXEL IN PROSTATE CAN

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 目的：初步探讨激素治疗前列腺癌根治术后前列腺癌患者经局部放疗联合多西紫杉醇化疗4个疗程后PSA下降率及PSA降至零的受试者数目。次要目标：确定该方案的耐受性、基于PSA进展的无进展生存、受试者的总体生存以及后续PSA失败的速度是否影响生存。第三个目标：记录失败患者的后续治疗，以及该治疗是否有反应。 研究计划：患者将在放疗期间接受7个周期的20 mg/m2/周(超过1小时)的多西紫杉醇治疗。然后多西紫杉醇75gm/m2静脉滴注(超过1小时)，每21天一次，共4个周期。初始辐射剂量为4500立方米。最后一次加量，总剂量为6840-6900cGy(4500/25加2340/13或2400/12)，共37次或38次。 方法：数据将在意向治疗的基础上进行分析。将汇总连续变量和分类变量的人口统计和基线特征的描述性统计数据。主要终点将被总结并进一步分析，使用Logistic回归来评估基线特征的影响，如人口统计学、术前PSA的速度等。对于次要终点，将使用Kaplan-Meier生存方法。此外，还将使用Cox回归来评估后续PSA失败的速度和其他变量是否会对生存率产生影响。 临床意义：RRP后持续PSA的患者是早期化疗的理想患者。他们显然有持续性疾病，但还不够大，不能公开。毫无疑问，除非他们死于其他原因，否则这些人注定会患上进行性转移性前列腺癌。在这组患者中，化疗是否对前列腺癌有效将是显而易见的。这一发现将与治疗高危乳腺癌患者持平，在高危乳腺癌患者中，如果给予辅助化疗，额外10%的患者会被治愈。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. OBJECTIVE: Primary Objective: To determine the rate of PSA decline and the number of subjects reaching a PSA nadir of zero following local irradiation combined with docetaxel chemotherapy followed by four courses of docetaxel in men with hormone-naive prostate cancer who fail to achieve a PSA nadir of zero following radical prostatectomy. Secondary Objectives: To confirm the tolerability of this regimen, the proression free survival based on PSA progression, the overall survival of subjects and if the velocity of subsequent PSA failure impacts on survival. Tertiary Objectives: To document subsequent therapy for failing patients and if there is a response to that therapy. RESEARCH PLAN: Patient will receive seven cycles of 20 mg/m2/week (over one hour) of docetaxel during irradiation. Then docetaxel 75 gm/m2 IV (over one hour) every 21 days for four cycles. The intial dose of Radiation will be 4500 cGY. With the final boost, the total dose will be 6840-6900 cGy (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions. METHODS: The data will be analyzed on an intent-to-treat basis. Descriptive statistics for demographic and baseline characteristics will be summarized for both continuous and categorical variables. The primary endpoint will be summarized, and further analyzed, using logistic regression to assess the impact of baseline characteristics such as demographics, velocity of PSA prior to surgery, etc. For the secondary endpoints, the Kaplan-Meier survival method will be used. In addition, the Cox regression will be used to assess if the velocity of subsequent PSA failure and other variables impact on survival. CLINICAL RELEVANCE: Patients with a persistent PSA after RRP are ideal patients to study with early chemotherapy. They clearly have persistent disease, but it is not bulky enough to be overt. There is no question, unless they die of something else, these men are destined to have progressive, metastatic prostate cancer. In this group of patients, it will be readily apparent whether chemotherapy is effective in curing prostate cancer. This finding would be on the par with treating high risk breast cancer patients where an additional 10% are cured if given adjuvant chemotherapy.