NCT03225235招募中不适用
Prospective Evaluation of Hypofractionated Stereotactic RT (SBRT) Using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer.
The Greater Poland Cancer Centre2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2013年8月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- survival time without biochemical recurrence,
研究概览
简要总结
The main purpose of study is to evaluate hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients with low and intermediate risk of progression prostate cancer.
详细描述
Evaluation of the usefulness expression of selected proteins (PTEN, SMAD4, Cyclin D1, SPP1) as prognostic and predictive factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •men from 40 to 75 years of age with a confirmed adenocarcinoma prostate, prostate biopsy will be performed <180 days prior to the randomization date,
- •completed assessment of tumor differentiation according to Gleason grading allows to perform stratification;
- •general Performance Status according to the Eastern Cooperative Oncology Group (ECOG) classification ( 0 -1),
- •belonging to the group of low and intermedium risk of progression; (cT1-cT2c, Gleason 7, PSA to 19.9 ng / ml), cT specified by AJCC 7 Edition (appendix 2),
- •PSA marked at least 10 days after or before the biopsy, and for patients taking phytosterol 30 days after discontinuation,
- •no distant metastases,
- •signing informed consent,
- •morphological and biochemical blood parameters within the normal limits.
排除标准
- •the presence of active cancer, except skin cancer preceding period 5 years prior to randomization,
- •surgical treatment (radical prostatectomy) or RT in the pelvic area,
- •co-morbidities that may significantly affect the expectancy life of the patients
- •do not meet the criteria for inclusion.
结局指标
主要结局
survival time without biochemical recurrence,
时间窗: 5 years
Phoenix definition of biochemical failure
次要结局
- survival time specific for prostate cancer,(5 years)
研究者
研究点 (2)
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