Observational and Prospective Study on the Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy (GenBx)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Prostate Cancer Diagnosis from Prostate Biopsy Report
研究概览
简要总结
Condition: Prostate cancer Intervention: Biopsy and inherited risk assessment
详细描述
Inherited genetic changes, including rare pathogenic mutations (RPMs) in several major genes and single nucleotide polymorphisms (SNPs)-based genetic risk scores (GRS) have been consistently associated with prostate cancer (PCa) risk. Furthermore, results from retrospective analyses of two clinical trials (PCPT and REDUCE) and biopsy cohorts revealed Caucasian men with higher GRS are 1) more likely to have positive biopsy and 2) have higher number of positive biopsy cores. These findings suggest inherited risk assessment may have clinical utility in identifying men who have a higher likelihood of positive results from diagnostic prostate biopsy. The objective of this observational trial is to confirm the clinical utility of both RPMs and GRS in a prospective study of multi-racial patients. Results from this trial will provide a critical piece of evidence for guideline committees to consider the adoption of inherited risk assessment in decision making for prostate biopsy.
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
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients undergoing prostate biopsy for detection of prostate cancer
- •Aged 40 to 69 years
- •Four ethnicity groups (Caucasian, African Americans, East Asians, Latinos)
- •PSA between 2.5-10 ng/mL
排除标准
- •Previous diagnosis of prostate cancer.
- •Ethnicity outside the inclusion criterion (including mixed ethnicity).
- •Any prior PSA test result outside the range of inclusion criterion.
结局指标
主要结局
Prostate Cancer Diagnosis from Prostate Biopsy Report
时间窗: 4 years
The primary outcome measure is prostate cancer diagnosis from the prostate biopsy report. The primary goal is to compare prostate cancer detection rate in patients of three inherited risk groups (high-risk, intermediate-risk, and low-risk).
次要结局
- The second type of secondary outcome measures is results from multi-parametric Magnetic Resonance Imaging (mpMRI), including(4 years)
- The first type of secondary outcome measures is demographic key clinical variables from chart review, including(4 years)
- The third type of secondary outcome measures is pathological variables from prostate biopsy, including(4 years)
研究者
Jianfeng Xu
Director of Program for Personalized Cancer Care
NorthShore University HealthSystem