NCT03597386撤回不适用
ConfirmMDx Assay is Multiparametric MRI (mpMRI) PIRADS Scored Lesions After a Negative MR/US Fusion Biopsy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Detection of prostate cancer based on rebiopsy of lesions on multiparametric MRI (mpMRI) following a negative MR/US fusion biopsy with concurrent systematic biopsy with correlation of ConfirmMDx assay testing performed on negative MR/US fusion biopsy
研究概览
简要总结
The purpose of this study is to see if the ConfirmMDx assay is useful in finding prostate cancer in patients who are at increased risk for prostate cancer based on elevated PSA and prostate lesion identified on mpMRI.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prior documented elevated PSA (> 4.0 ng/ml)
- •MRI lesion based on PIRADS scoring within the past 3 years
- •Completed MR/US fusion prostate biopsy with concurrent systematic biopsy for PIRADS score 2-5 with negative pathological findings completed subsequent ConfirmMDx assay (regardless of result). The most recent biopsy can be within 4 years if ConfirmMDx already completed.
- •May have had prior negative biopsy sessions prior to the most recent MR/US fusion biopsy
- •Must be able to stop anticoagulation/antiplatelet therapy 5-7 days prior to obtaining biopsy
- •Ability to give informed consent
排除标准
- •Any metastatic cancer
- •Any prostate cancer
- •Active infection: urinary tract infection or prostate infection precluding prostate biopsy
- •Anal stenosis or severe anal disease preventing prostate biopsy
结局指标
主要结局
Detection of prostate cancer based on rebiopsy of lesions on multiparametric MRI (mpMRI) following a negative MR/US fusion biopsy with concurrent systematic biopsy with correlation of ConfirmMDx assay testing performed on negative MR/US fusion biopsy
时间窗: baseline
次要结局
- Correlation of prostate cancer detection on re-biopsy with ConfirmMDx testing outcomes(baseline)
- Correlation of PIRADS scores with ConfirmMDx testing outcomes(baseline)
- Compare prostate cancer detection rates for repeat MR/US fusion biopsy after prior negative biopsy(baseline)
研究者
Hani Rashid
Professor, Urology
University of Rochester
研究点 (1)
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