Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of clinically significant prostate cancer (csPCa)
研究概览
简要总结
This project aims to evaluate the role of fully hybrid PET/MRI with 18FPSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa).
Our main hypothesis is that adding 18F-PSMA PET to mpMRI prior to biopsy, will reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy
- •Feasibility to undergo all procedures listed in protocol
- •Ability to provide written informed consent
排除标准
- •Prior diagnosis of prostate cancer
- •Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min)
- •Contraindication to prostate biopsy
结局指标
主要结局
To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of clinically significant prostate cancer (csPCa)
时间窗: PET/MRI: day 0 prostate biopsy: day 0-90 days
Diagnostic accuracies of 18F-PSMA PET and mpMRI will be calculated by means of sensitivity: true positive/(true positive + false negative) and specificity: true negative/(false positive + true negative) using the prostate biopsy result as reference standard.
次要结局
- To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone To report the reduction in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET(PET/MRI: day 0 prostate biopsy: day 0-90 days)