Longitudinal, Randomized, Open and Prospective Clinical Trial to Evaluate the Efficacy of Continuous vs Intermittent Maximum Androgen Blockade (CMAB vs IMAB) With Goserelin-Bicalutamide Combination in the Treatment of Hormonal naïve With Metastatic Prostate Cancer

AstraZeneca2 个研究点分布在 1 个国家目标入组 15 人开始时间: 2004年8月1日最近更新: 2007年8月28日

适应症

试验速览

阶段: 4 期
状态: 撤回
发起方: AstraZeneca
入组人数: 15
试验地点: 2
主要终点: Time to progression

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate the efficacy, safety and survival of two treatment regimens: Continuous Intermittent Maximum Androgen Blockade, using goserelin and bicalutamide in patients with prostate cancer. Primary endpoint is time to progression. Fifteen patients will be evaluated. QoL evaluation is also included.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

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

•Histological diagnosis of D2 of Adenocarcinoma,
•Naivety to treatment
•Valuable bone metastasis

排除标准

•Hematological, liver or renal toxicity Grade IV
•Severe and active infections

结局指标

主要结局

Time to progression

次要结局

Safety
Quality of Life

研究者

发起方

AstraZeneca

申办方类型

Industry

研究点 (2)

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