NCT02300389已完成不适用
Randomized, Multi-center Clinical Trial Comparing Hypofractionated Radiotherapy Boost to Conventionally Fractionated in a High Risk Group of Prostate Cancer Patients
The Greater Poland Cancer Centre6 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2011年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 288
- 试验地点
- 6
- 主要终点
- biochemical Progression Free Survival (bPFS)
研究概览
简要总结
The main purpose of study is to compare the effectiveness of Hypofractionated IMRT boost Radiotherapy to Conventional IMRT boost Radiotherapy for high-risk prostate cancer patients combined with Androgen Deprivation Therapy.
详细描述
Additional objectives of the study for high-risk (non-metastatic) prostate cancer patients are as follows:
- Analysis of number of circulating tumor cells in peripheral blood as a prognostic/predictive factors for survival.
- Analysis of miRNA expression levels (100, 141 and 143) in peripheral blood as a prognostic and predictive factors.
- Evaluation of the usefulness expression of selected proteins (PTEN, SMAD4, Cyclin D1, SPP1) as prognostic and predictive factors.
- Evaluation of the usefulness of the expression level of antigen-specific T cells, B-and NK cells as a prognostic factors.
- Evaluation of usefulness of the fiducial markers for localizing the prostate gland position during irradiation for the selected control imaging methods (2DkV, CBCT, MVCT).
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
- Single (Participant)
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 old with confirmed prostate adenocarcinoma, prostate biopsy will be performed <180 days before the date of randomization,
- •completed assessment of tumor differentiation according to Gleason grading allows to perform stratification; Gleason score ≤ 7 versus Gleason score> 8,
- •general condition according to the classification of the Eastern Cooperative Oncology Group (ECOG) 0 - 1), (Appendix 1),
- •Androgen Deprivation Therapy: prior Radiotherapy (RT) (minimum 3 months before the start of RT), concurrently with RT and after RT during follow-up (24 months) ,
- •high risk of Prostate Cancer progression defined as presence of at least one of the following factors: cT3, Gleason> 7, PSA> 20 ng / ml or presence of at least two of cT2c, Gleason 7, PSA in the range of 10.1 ng / ml to 19.9 ng / ml, cT defined by AJCC staging 7 edition, (Appendix 2),
- •PSA identified at least 10 days after the biopsy or before, and patients receiving fiansteryd 30 days after the cessation of therapy,
- •no regional and distant metastases confirmed by bone scintigraphy, chest radiograph, computed tomography/magnetic resonance imaging of the pelvis,
- •signing an informed consent to participate in a medical experiment (radiotherapy + biological material samples) (Annex 3),
- •morphological and biochemical parameters within normal limits.
排除标准
- •the presence of active cancer except skin cancer preceding period of 5 years prior to randomization,
- •Early surgery (radical prostatectomy) or pelvic RT,
- •earlier hormonal therapy than is advocated in this study,
- •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
biochemical Progression Free Survival (bPFS)
时间窗: 5 years
Phoenix definition of biochemical failure
次要结局
- Overall Survival (OS)(5years)
- Cause Specific Survival (CSS)(5 years)
研究者
研究点 (6)
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