NCT01615965Unknown不适用
Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer
Technical University of Munich2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Biochemical recurrence free survival
研究概览
简要总结
The purpose of this study is to set up a model for detecting micrometastases in Lymph nodes of patients with prostate cancer by quantitative polymerase chain reaction and its impact on progression-free survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Histologically confirmed prostate cancer
- •Locally operable tumor
- •Negative bone scan (obligatory if Gleason Score > 7 or PSA > 20ng/ml
- •Karnofsky ≥ 80%
- •Age 18 - 75 years
- •Informed consent in written form
- •Sufficient hematologic, coagulatory and renal function
- •Compliant patient and geographic precondition for adequate follow-up given
排除标准
- •Manifest secondary tumor
- •Organ metastases on CT-scan /MRI or in Histology
- •Myocardial infarction or stroke within the last 6 months
- •Severe cardiovascular (Grade III - IV according to NYHA), pulmonary (pO2 < 60 mmHg), renal, hepatic oder hematopoetic impairment
- •Severe active or chronic infection (z.B. pos. HIV-Antibody-Test, HBs-Ag-detected in Serum and/ or chronic Hepatitis)
- •Severe psychiatric disease
- •Previous chemotherapy
- •Previous pelvine radiotherapy
结局指标
主要结局
Biochemical recurrence free survival
时间窗: 2 years
Influence of molecularbiologic micrometastases in lymph nodes on biochemical recurrence free survival in comparison with patients who have histopathologic macrometastases or no evidence of lymph node metastases
次要结局
- Frequency of molecular detected lymph node micrometastases according to their topography(2 years)
研究者
研究点 (2)
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