临床试验/NCT00908674

NCT00908674已完成不适用

Measure of Androcur Effects on Quality of Life at Prostate Cancer Patients

Bayer0 个研究点目标入组 245 人开始时间: 2008年6月最近更新: 2010年4月13日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Bayer
入组人数: 245
主要终点: Quality of life change measured by SF-35 questionnaire

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Androcur is an antiandrogenic drug, which blocks the action of male sex hormones. Androcur is used for treatment of advanced prostate cancer. This study investigates the effect of Androcur on quality of life of prostate cancer patients who are taking the drug for 12 months

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

•Histologically confirmed adenocarcinoma of the prostate
•Inoperable prostate tumor or progradiated after surgery/ irradiation therapy
•Locally advanced tumor or distant metastases is present

排除标准

•Patient not fulfil the recruitment criteria
•Liver disease; Dubin-Johnson syndrome; Rotor syndrome; previous or existing liver tumours (in carcinoma of the prostate only if these are not due to metastases); wasting diseases (with the exception of carcinoma of the prostate); depression; previous or existing thromboembolic processes; diabetes with vascular changes; sickle-cell anaemia.
•As regards patients with prostatic carcinoma who have a history of thromboembolic processes and/or an existing sickle-cell anaemia, or diabetes with vascular changes, the risk:benefit ratio must be considered carefully in each individual case before the use of Androcur

研究组 & 干预措施

Group 1

干预措施: Cyproterone acetate (Androcur) (Drug)

结局指标

主要结局

Quality of life change measured by SF-35 questionnaire

时间窗: Baseline, after 3, 6 and 12 month

次要结局

未报告次要终点

研究者

发起方

Bayer

申办方类型

Industry

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