Validation of Radioisotope Guided Lymphadenectomy for Loco-regional Staging in Patients With Intermediate or High-risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 2
- 主要终点
- Number of sentinel nodes radiolabeled
研究概览
简要总结
The diagnosis of a ganglionic infringement(achievement) at a patient reached (affected) by a prostate cancer is a factor(mailman) of bad forecast. The locoregional ganglionic staging is a very important element in the coverage (care). He allows to determine the local extension of the disease and the type(chap) of therapeutics to implement(operate) after the surgery. The standard cleaning out at present recommended by the European company (society) of urology at the patients at intermediate or high risk of second offense (recurrence) after local treatment(processing), has to concern the obturating pit, the internal and external iliac territories. However this type(chap) of cleaning out does not seem to solve all the problems of locoregional stratification. Indeed, several studies concerning the radio-controlled cleaning out highlighted that 10 in 30% of ganglions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject man, whose age is greater than or equal to 18 years
- •Carrier of cancer intermediate risk non-metastatic prostate or high relapse
- •Subject with an initial balance sheet expansion, regional and general negative by Scanner, abdominopelvic MRI or bone scan,
- •Subject has undergone a medical examination in connection with the study,
- •Topic for which a radical prostatectomy is considered curative purposes,
- •Supported by Subject surgical teams involved in the study,
- •Topic affiliated to a social security scheme,
- •Subject who signed informed consent.
排除标准
- •Subject man, whose age is less than 18 years
- •Subject who have received hormone therapy or radiation therapy for prostate cancer
- •Subject who had surgery for prostate adenoma (transurethral resection or open surgery) because of potential difficulties injection of radioactive tracer in the gland,
- •Subject has a history of pelvic surgery or radiotherapy,
- •Subject with inguinal hernia repair history of laparoscopic,
- •Subject refusing blood transfusions,
- •Subject is not agreeing to participate in this study and did not sign the informed consent.
结局指标
主要结局
Number of sentinel nodes radiolabeled
时间窗: 54 months
Number of sentinel nodes radiolabeled radiolabeled in the area of standard cleaning
次要结局
未报告次要终点