Prospective Study of Natural Killer Cells in Patients With Metastatic Prostate Cancer: Relationship With Survival and Response Time to Castration
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Response time to castration
研究概览
简要总结
Prospective research of Natural Killer cells as predictive biomarkers to stratify patients likely to have longer response time to castration.
详细描述
The main objective is to validate prospectively the results of a retrospective study showing a correlation between the level of NKp30 and NKp46 receptor-activators expression on the surface of NK cells and 1) the survival time, 2) the response time to castration in patients with metastatic prostate cancer.
Prospective monocenter, open-label study.
During a visit in the frame of management of the disease, a single blood sample will be collected. Patients will then have a standard care follow-up for a period of 5 years. Follow up data (death, progression) will be collected every 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Patient with metastatic prostate cancer.
- •Aged of 18 years or more.
- •Patient in period of sensitivity to castration (patient non castrated or castration performed less than 1 year ago) and lack of progression.
- •Patient having signed an informed consent.
- •Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen.
排除标准
- •Patient under chemotherapy treatment at the time of sampling
- •Patient under corticotherapy treatment at the time of sampling
- •Patient in emergency situation, adult subject to a measure of legal protection (placed under judicial protection, tutorship, or curatorship), or unable to give consent.
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study medical follow-up
- •Contraindications to study procedure
结局指标
主要结局
Response time to castration
时间窗: every 6 months during 3 years-follow up
Time of occurrence of: * confirmed PSA rise + serum testosterone \< 0.50 ng/mL * and/or radiological progression according to the modified PCWG2 criteria (progression according to the RECIST criteria v1.1 or documented by the appearance of at least 2 new lesions on the bone scan)
Survival
时间窗: every 6 months during 3 and 5 years-follow up
次要结局
- Tumor volume(at diagnostic (before inclusion in the study))
- Level of alcaline phosphatase(at diagnostic (before inclusion in the study) and at time of treatment for progression in the course of 3 years-follow-up)