A Single-arm, Multicenter Prospective Study to Evaluate the Diagnostic Performance of PROSTest in Men With PSA ≥ 3ng/ml Using Biopsy as the Sole Ground Truth
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of the PROSTest to detect prostate cancer at biopsy
研究概览
简要总结
This prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and/or abnormal digital rectal examination, with or without pre-biopsy MRI. Peripheral blood will be collected prior to biopsy for PROSTest analysis. Biopsy histopathology will serve as the reference standard. PROSTest results will be analyzed blinded to pathology.
详细描述
This prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and/or abnormal digital rectal examination, with or without pre-biopsy MRI. Peripheral blood will be collected prior to biopsy for PROSTest analysis. Biopsy histopathology will serve as the reference standard. PROSTest results will be analyzed blinded to pathology. Diagnostic performance metrics including sensitivity, specificity, negative predictive value, and area under the receiver operating characteristic curve will be calculated. Decision-curve analyses will assess potential reductions in unnecessary biopsies. Exploratory analyses will evaluate correlations between PROSTest scores, MRI findings, and pathologic grade group.
Endpoints: Primary endpoint is diagnostic accuracy of PROSTest for PCa detection. Secondary endpoints include negative predictive value, correlation with Gleason grade group, and incremental performance of PROSTest when combined with PSA and MRI.
Trial Status: IRB approval is complete. Enrollment is expected to begin in March 2026, with a planned sample size of approximately [1,500] participants.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •elevated PSA and/or abnormal digital rectal examination
排除标准
- •Previous Prostate cancer diagnosis
结局指标
主要结局
Diagnostic accuracy of the PROSTest to detect prostate cancer at biopsy
时间窗: Following completion of the study. Study is anticipated to enroll over a year and be completed within 18 months. Samples will be evaluated at study end.
Primary endpoint is diagnostic accuracy of PROSTest for PCa detection. Assay is scored 0-100 and has a cut-off of 50 for normal. A blood sample with a PROSTest score \> or equal than 50 are predicted to be a prostate cancer. The expectation is that \>85% of individuals who are biopsy positive are also PROSTest-positive. We anticipate \~400 individuals will be biopsy positive. Conversely, the expectation is that \>75% of individuals who are biopsy negative will also be PROSTest-negative. We anticipate \~600 individuals will be biopsy negative. This will allow us to derive diagnostic metrics for the assay using biopsy-status as the gold standard.
次要结局
- Diagnostics metrics for the PROSTest(Following completion of the study. Study is anticipated to enroll over a year and be completed within 18 months. Samples will be evaluated at study end.)