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

临床试验：评估前列腺癌中放射和多西他赛的 II 期研究

• 批准号: 7718724
• 负责人: Gregory J Swanson
• 金额: $ 0.03万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718724
• 关键词: Adjuvant Chemotherapy; Cancer Patient; Characteristics; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Data; Disease; Disease regression; Dose; End Point; Failure; Funding; Grant; Hormones; Hour; Institution; Logistic Regressions; Malignant neoplasm of prostate; Metastatic Prostate Cancer; Methods; Numbers; Operative Surgical Procedures; PSA Velocity; Patients; Phase; Prostate; Radiation; Radical Prostatectomy; Rate; Research; Research Personnel; Resources; Risk; Source; Treatment Protocols; United States National Institutes of Health; Week; base; chemotherapy; clinically relevant; day; demographics; docetaxel; irradiation; malignant breast neoplasm; men; response; statistics

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 目的：主要目标：确定局部照射后PSA下降率和达到零PSA NADIR的受试者的数量，结合多西他赛化疗，然后在患有激素的前列腺癌男性中进行了四个疗程的多西他赛，他们未能实现自自由期前列腺切除术后零零的PSA NADIR。 次要目标：确认该方案的耐受性，基于PSA的进展，受试者的整体存活以及随后的PSA失败的速度对生存的速度， 第三级目标：记录患者失败的后续治疗，以及是否对该疗法有反应。 研究计划：在辐照过程中，患者将接受7个周期为20 mg/m2/周（超过一小时）的周期。 然后，每21天，每21天以上，多西他赛75 gm/m2 IV（超过一小时）进行四个周期。 辐射的直觉剂量将为4500 CGY。 随着最后的提升，总剂量为6840-6900 CGY（4500/25加2340/13或2400/12），总剂量为37或38个分数。 方法：将以意图对处理进行分析数据。 对于连续变量和分类变量，将总结人口统计和基线特征的描述性统计。 将汇总主要终点，并使用逻辑回归进行进一步分析，以评估基线特征，例如人口统计学，手术前PSA速度等。对于次要终点，将使用Kaplan-Meier生存方法。 此外，COX回归将用于评估随后的PSA失败的速度和其他变量对生存的影响。 临床相关性：RRP后具有持续性PSA的患者是早期化疗研究的理想患者。 他们显然患有持续性疾病，但不够笨重，无法公开。 毫无疑问，除非他们死于其他事情，否则这些人注定要患有进步的转移性前列腺癌。 在这组患者中，化学疗法是否可以有效治愈前列腺癌，很容易看出。 这一发现将与治疗高风险乳腺癌患者相提并论，如果给予辅助化疗，则额外的10％可以治愈。