Molecular, Genetic, and Genomic Assessments of MTOR Inhibition in Metastatic Hormone-Refractory Prostate Cancer Tissue From Patients Treated With RAD001
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Functional extent of mTOR inhibition in the phosphorylation status of S6K and CA IX protein in prostate tumors from patients treated with RAD001.
研究概览
简要总结
The purpose of this study is to look at the genetic changes that RAD001 causes in prostate cancer cells and how those changes relate to patients' response to RAD001 treatment.
详细描述
This correlative science study will be a minimum risk assessment of tumor and plasma samples collected as part of a Phase II clinical trial of RAD001 in patients with HRPC. Prior to enrollment or at the time of signing consent in the Phase II trial, patients will be approached to participate in the correlative science study. Patients who agree to participate will be assigned a separate study number which will be used to identify their molecular, genetic, genomic and biomarker assessments using the tumor and plasma samples. Clinical outcome results from the accompanying Phase II trial will be used for correlative assessments in this study, however, results from this correlative science study will be kept separate from the assessments and reporting of the clinical trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients must be enrolled in the clinical study entitled: A Single Arm, Phase II Study of RAD001 in Patients with Metastatic, Hormone-Refractory Prostate Cancer at the time of enrollment onto this study.
排除标准
- 未提供
结局指标
主要结局
Functional extent of mTOR inhibition in the phosphorylation status of S6K and CA IX protein in prostate tumors from patients treated with RAD001.
时间窗: pre-treatment, day 29, and monthly blood samples
次要结局
- To identify candidate plasma markers of glycolysis that reflect tumor AKT activity.(pre-treatment, day 29, and monthly blood samples)
- To determine by comparative genomic hybridation (CGH) loss of heterozygosity (LOH) patterns of the 10q23 locus (to assess PTEN status) and other sites of chromosomal alterations associated with pathologic response to mTOR inhibition.(pre-treatment, day 19, and monthly blood samples)
- To identify expression profiles associated with AKT activation and RAD001 treatment effect.(pre-treatment, day 29, and monthly blood samples)