PASCUAL (Prostate Assay Specific Clinical Utility at Launch) Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- MDx Health
- 入组人数
- 600
- 试验地点
- 15
- 主要终点
- The primary objective is to demonstrate the clinical utility of the ConfirmMDx test
研究概览
简要总结
The main hypothesis of this study is to demonstrate that the use of the ConfirmMDx for Prostate Cancer test in previously biopsied patients improves urologists' patient management by reducing unnecessary repeat biopsies, attendant procedure costs, and potential adverse events in men being considered for a repeat procedure.
详细描述
The results of the study will reveal the clinical utility of this test by analyzing the physicians' use of negative or positive assays compared to patients managed using SOC methods without assay findings. The repeat biopsy rate at 12 months from study entry will be used for the primary endpoint analysis. All patients will be followed for 24 months from the date of the previous negative biopsy to evaluate an extended period of observation to track repeat biopsies and cancer detection.
The primary objective of this study is to demonstrate a lower repeat biopsy rate by using the negative results of ConfirmMDx for Prostate Cancer in practice rather than current SOC. All patients will have the tissue from their previous negative biopsy tested with the assay. Only data from Cases (informed of ConfirmMDx assay results) and Controls (blinded of the ConfirmMDx assay result) patients with negative test results will be used for the primary objective.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged 40 to 75 years old* that underwent a previous cancer-negative prostate biopsy within 15 months and being considered for a repeat biopsy due to persistent or elevated cancer-risk factors
- •The previous negative prostate biopsy must have collected a minimum of 8 tissue cores and remaining FFPE tissue from all cores should be available for testing
- •Minimum tissue volume criteria of 20 microns of prostate biopsy core tissue should be available (40 microns preferable)
- •The presence of HGPIN (high-grade prostatic intraepithelial neoplasia), PIA (proliferative inflammatory atrophy), or glandular inflammation reported in the first biopsy histopathology report is acceptable for entry.
排除标准
- •Prior diagnosis of prostate cancer or cellular atypia suspicious for cancer (ASAP) in a previous biopsy histology report.
- •Patients being managed by Active Surveillance for low stage prostate cancer
- •Men greater than 75 years old (generally not considered for repeat biopsy)
- •Most recent biopsy was a saturation biopsy (> 24 tissue cores).
- •Tissue extracted using transurethral resection of the prostate (TURP) procedures rather than standard patterned biopsy core extraction.
- •Subjects who had been previously tested with ConfirmMDx.
结局指标
主要结局
The primary objective is to demonstrate the clinical utility of the ConfirmMDx test
时间窗: 2 years
The primary objective is to demonstrate a lower repeat biopsy rate by using the negative results of ConfirmMDx for Prostate Cancer in practice rather than current SOC.
次要结局
- Compare rebiopsy rates assay negative results in cases and controls(2 years)
- Compare rebiopsy rates in assay positive group vs standard of care(2 years)
- Compare rebiopsy rates of case and controls(2 years)
- Evaluate clinical utility and cost savings by using the ConfirmMDx test(2 years)
- Analyse cancer detection rates(2 years)
- Compare rebiopsy rates assay positive results in cases and controls(2 years)