To Characterize Tumor Hypoxia by Magnetic Resonance Imaging in African American and Caucasian Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of Biomarkers Expressed
研究概览
简要总结
The purpose of this research study is to measure the hypoxia (low oxygen condition) in prostate cancers and its effect in survival. In this study, investigators will assess hypoxia by magnetic resonance imaging (MRI) and create a hypoxia score. Investigators will study the hypoxia score and how it correlates (if any) to the disease aggressiveness as well as its effect on the treatment outcomes.
详细描述
Primary Objective(s):
- To assess hypoxia in primary prostate tumors by magnetic resonance imaging.
- To correlate hypoxic score with disease aggressiveness (proliferation biomarkers' expression).
Secondary Objective(s):
- To correlate hypoxic score with ExoHypoxic concentration in plasma of same patient.
- To correlate hypoxic score with fatty acid synthase (FASN) expression.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The minimum age for this study is men 40 years and older. Prostate cancer mainly affects men over the age of
- •Patients with Caucasian and African American race
- •Patients with pathology-proven prostate cancer (Gleason 6 or higher)
- •Patients who have not yet undergone therapy (systemic drugs, radiation, or prostatectomy)
- •Patients who will have a radical prostatectomy as standard of care.
- •Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
排除标准
- •Patients who have already received some form of treatment or are not planning to undergo radical prostatectomy for treatment.
- •Patients with any other cancer along with prostate cancer.
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
结局指标
主要结局
Number of Biomarkers Expressed
时间窗: 30 days
Expression of proliferation biomarkers (Ki-67 and PCNA) to calculate the correlation coefficients estimates between expression of proliferation biomarkers using Pearson correlation coefficient and Spearman's rank correlation coefficient.
Differences in Tumor Hypoxia Scores Between Subgroups
时间窗: 30 days
Using MRI parameters including apparent diffusion coefficient and fractional blood value four race/score combination groups (African-Americans with Gleason score 6; African-Americans with Gleason score greater than or equal to 7; Caucasians with Gleason score 6; and Caucasian with Gleason score greater than or equal to 7) to calculate the correlation coefficients estimates between hypoxic scores using Pearson correlation coefficient and Spearman's rank correlation coefficient.
次要结局
- ExoHypoxic Concentrations in Plasma(30 days)
- Number of Fatty Acid Synthase Expressions in Prostate Cancer and ExoHypoxic Concentrations(30 days)