A multi-center randomized phase II study to evaluate the combination therapy of substitution of antiandrogens and tegafur-uracil for castration resistant prostate cancer - The combination therapy of substitution of antiandrogens and tegafur-uracil

Department of Urology, Institute of Health Biosciences, The University of Tokushima Graduate School0 个研究点目标入组 90 人开始时间: 2012年10月26日最近更新: 2023年10月17日

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 90

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Fifty-two patients were enrolled in this study. Median age was 77 (47-92) years old. PSA response rate in group B (61.5%) tended to be higher than that in group A (34.6%) (p=0.0950). Group B (15.9 months) had significantly longer median time to PSA progression (TTP) than group A (6.4 months) (p=0.0137). In group B, patients with low TS (81.8%) tended to have higher PSA response rate than those with high TS (46.2%). In addition, among the patients with low TS, group B have shown significantly longer TTP than group A (p=0.0175). There were no severe AEs in both treatment groups.

研究设计

研究类型: Interventional

入排标准

年龄范围: ot applicable 至 ot applicable（—）
性别: Male

入选标准

未提供

排除标准

•1.past history of radiotherapy or prostatectomy 2.past history of allergic reactions 3.use phenytoin 4.contraindication of tegafur-uracil 5.active infection 6.serious complications 7.other cancer requiring treatment 8.judged inappropriate for the clinical trial by doctor

研究者

发起方

Department of Urology, Institute of Health Biosciences, The University of Tokushima Graduate School

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