A Prospective, Randomized Blinded, Shared Decision Impact Trial of the ExoDx Prostate (IntelliScore), EPI Test, in Men Presenting for Initial Biopsy.
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Evaluate performance of the ExoDx Prostate(IntelliScore)
研究概览
简要总结
The purpose of this research study is to investigate the utility of a validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy.
详细描述
Primary Objective(s)
- Evaluate performance of the ExoDx Prostate(IntelliScore) (EPI) to reduce the number of initial prostate biopsies by greater than or equal to 15% for men with an elevated Prostate-Specific Antigen 2-10ng/mL presenting for a biopsy in consultation with their urologist.
- Compare performance of both the ExoDx Prostate(IntelliScore) 15.6 and 20 cut-points with respect to the biopsy decision process.
- Assess physician satisfaction with the ExoDx Prostate(IntelliScore) report including test result presentation, graphics and interpretation.
- Assess urologist / patient satisfaction for ease of understanding test results and role on biopsy decision process.
Secondary Objectives
- Determine the medical economic impact of the ExoDx Prostate(IntelliScore) test in the prostate biopsy decision process.
- Correlation of the ExoDx Prostate(IntelliScore) score with the actual biopsy result by utilizing the Receiver Operating Characteristic of the Area Under Curve for discriminating high-grade (greater than or equal to Gleason Score 7, International Society of Urological Pathology 2 and 3) from low-grade (Gleason Score 6, International Society of Urological Pathology 1) and benign disease on initial prostate needle biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Investigator)
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.
- •Known hepatitis (all types) and/or HIV documented in patient's medical record.
- •Patients with history of concurrent renal/bladder tumors.
研究组 & 干预措施
Cohort A
Patients randomized to Cohort A will receive ExoDx Prostate (IntelliScore) test results along with a post-ExoDx Prostate (IntelliScore) test result questionnaire to evaluate impact of test results in the biopsy decision process, utility, ease of understanding and work-flow implementation.
干预措施: ExoDx Prostate (IntelliScore) (Diagnostic Test)
Cohort B
Patients randomized to Cohort B will proceed with conventional standard of care.
结局指标
主要结局
Evaluate performance of the ExoDx Prostate(IntelliScore)
时间窗: 6 Months
Evaluate performance of the ExoDx Prostate(IntelliScore) to reduce the number of initial prostate biopsies by greater than or equal to 15% for men with an elevated prostate specific antigen between 2-10ng/mL presenting for a biopsy in consultation with their urologist.
次要结局
未报告次要终点