Equivalency of MyProstateScore (MPS) Results Between Urine Samples Collected With or Without a Preceding Digital Rectal Examination
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- MPS equivalency with and without DRE
研究概览
简要总结
The purpose of the study is to quantify the concordance of MPS results between first-catch urine samples collected post-DRE and those collected without a DRE.
详细描述
The process for obtaining a urine sample for MPS currently requires a DRE within one hour prior to urine collection. We aim to understand whether a DRE is a required step prior to urine collection for MPS, and to explore alternative methods that may eliminate the need for a DRE. In order to do so, we will perform a crossover study in which each subject provides a sample under both conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient is a candidate for prostate biopsy (Bx)
- •If Bx naïve and ≤75yo then PSA 3-10 ng/mL
- •If Bx naïve and >75yo then PSA 4-10 ng/mL
- •If prior negative Bx then PSA may exceed 10 ng/mL
- •If DRE very suspicious, then PSA below the thresholds of 3 ng/mL (≤75yo) and 4 ng/mL (>75yo) are acceptable
排除标准
- •- Prior diagnosis of prostate cancer
结局指标
主要结局
MPS equivalency with and without DRE
时间窗: Study participation will span 8 days
The process for obtaining a urine sample for MPS currently requires a DRE within one hour prior to urine collection. We aim to understand whether a DRE is a required step prior to urine collection for MPS, and to explore alternative methods that may eliminate the need for a DRE.
MPS validity rate with and without DRE
时间窗: Study participation will span 8 days
Rate of invalid test result equivalency in post-DRE versus non-DRE paired urine samples. Rate will be measured as the percentage of subjects who return an invalid urine sample.
次要结局
未报告次要终点