I-125 Versus Pd-103 for Medium Risk Prostate Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 660
- 试验地点
- 4
- 主要终点
- PSA-based cancer eradication
研究概览
简要总结
hypothesis: the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.
A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10-20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy).
详细描述
Objective: The objective of this study is test the hypothesis that the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.
Research plan:
A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10-20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy).
Methodology:
Randomization will be accomplished by the method of random permuted blocks.
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
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •PSA 4-10 ng/ml
- •Gleason score 5 or 6
排除标准
- 未提供
结局指标
主要结局
PSA-based cancer eradication
次要结局
未报告次要终点