NCT00319787已完成2 期
A Randomized Placebo Controlled Study to Assess the Rate of PSA Decrease, Anatomical & Metabolic Changes in the Prostate Determined by MRI/3D-MRS & Histological Changes by Biopsy in Subjects With Locally Advanced Prostate Carcinoma Treated With Either Casodex® (Bicalutamide) Alone or the Combination of Casodex® & ZD1839 (Iressa™)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- Determine the difference in the rate of PSA decrease between treatments over a 6 months period.
研究概览
简要总结
The purpose of this study is to determine if the addition of ZD1839 Iressa™ to standard treatment with Casodex® (bicalutamide) for locally advanced prostate cancer can detect a difference in the rate of decrease of prostate specific antigen (PSA) levels.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years of age. Men with histologically confirmed locally advanced prostatic adenocarcinoma
排除标准
- •No prior treatment for prostate cancer, including surgery, radiotherapy, cryotherapy or thermotherapy. No abnormal laboratory values. No co-existing malignancies and any other significant clinical disorder or laboratory finding.
结局指标
主要结局
Determine the difference in the rate of PSA decrease between treatments over a 6 months period.
次要结局
- To detect changes in prostatic metabolites by using in vivo magnetic resonance spectroscopy (MRS)
- To detect changes in prostate gland using magnetic resonance imaging (MRI)
- To detect changes in serum tumor markers
- To assess histopathological changes
研究者
研究点 (3)
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