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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 目的：主要目的：确定未接受激素治疗的前列腺癌男性根治性前列腺切除术后 PSA 最低值未达到零的男性，在局部放疗联合多西他赛化疗后接受四个疗程的多西他赛治疗后，PSA 下降率和达到 PSA 最低值零的受试者人数。 次要目标：确认该方案的耐受性、基于 PSA 进展的无进展生存期、受试者的总体生存期以及随后 PSA 失败的速度是否对生存期产生影响。 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：患者在照射期间将接受七个周期的 20 mg/m2/周（超过一小时）的多西紫杉醇。 然后每 21 天注射多西紫杉醇 75 gm/m2 IV（超过一小时），共四个周期。 辐射的初始剂量将为 4500 cGY。 最后一次加强剂量为 6840-6900 cGy（4500/25 加 2340/13 或 2400/12），总共 37 或 38 个分次。 方法：数据将在意向治疗的基础上进行分析。 人口统计和基线特征的描述性统计将针对连续变量和分类变量进行总结。 将使用逻辑回归对主要终点进行总结和进一步分析，以评估基线特征（例如人口统计、术前 PSA 速度等）的影响。对于次要终点，将使用 Kaplan-Meier 生存法。 此外，Cox 回归将用于评估随后 PSA 失败的速度和其他变量是否对生存产生影响。 临床相关性：RRP 后 PSA 持续存在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，但其规模还不足以明显。 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，化疗是否能有效治愈前列腺癌是显而易见的。 这一发现与治疗高危乳腺癌患者的情况相当，如果接受辅助化疗，另外 10% 的患者可以治愈。