Clinical Evaluation of the 'ExoDx Prostate IntelliScore' in Men Presenting for Initial Biopsy; Additional Confirmation Study Including Impact on Decision-making and Health Economics.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 532
- 试验地点
- 18
- 主要终点
- Confirm performance of the ExoDx Prostate IntelliScore
研究概览
简要总结
The purpose of this research study is investigate a new and validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy The current protocol has two objectives; one is to further assess and evaluate the performance of the urine test in men already scheduled for initial prostate needle biopsy (cohort (group) 1) and two, to evaluate how the results of the urine test influences the decision process for determining whether to perform a prostate biopsy (cohort (group) 2).
详细描述
Primary Objective(s)
- Confirm performance of the ExoDx Prostate (IntelliScore) (EPI) utilizing a designated collection vessel for men presenting for their initial prostate biopsy with an elevated Prostate-specific antigen (2-10 ng/mL).
- Evaluate impact of the confirmed ExoDx Prostate (IntelliScore) on the decision to perform an initial prostate biopsy for men presenting with an elevated Prostate-specific antigen (2-10 ng/mL).
Secondary and Exploratory Objectives
- Assess physician satisfaction with the ExoIntelliScore Prostate report including test result presentation, graphics and interpretation.
- Assess patient satisfaction for ease of understanding test results and role on decision process to have a biopsy.
- Determine the medical economic impact of the ExoIntelliScore Prostate in the prostate biopsy decision process.
- Correlation of the ExoIntelliScore Prostate score with the actual biopsy result.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •50 years of age
- •Clinical suspicion for prostate cancer
- •Elevated Prostate-specific antigen between: 2.0 - 10 ng/ mL
- •No clinical history of a prior negative biopsy
排除标准
- •History of prior prostate biopsy.
- •Use of medications or hormones that are known to affect serum Prostate-specific antigen levels within 3-6 months of study enrollment.
- •Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
- •History of prostate cancer.
- •History of invasive treatments for benign prostatic hypertrophy (Benign Prostatic Hyperplasia) or lower urinary track symptoms within 6 months of study enrollment.
- •No known hepatitis (all types) and/or HIV documented in patient's medical record.
- •Patients with history of concurrent renal/bladder tumors.
结局指标
主要结局
Confirm performance of the ExoDx Prostate IntelliScore
时间窗: 6 months
Confirm performance of the ExoDx Prostate IntelliScore utilizing a designated collection vessel for men presenting for their initial prostate biopsy with an elevated prostate-specific antigen (2-10 ng/mL).
次要结局
未报告次要终点