Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 167
- 主要终点
- To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone
研究概览
简要总结
This project aims to evaluate the role of fully hybrid PET/MRI with 18F-PSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa).
This prospective PET/MRI clinical evaluation will ideally 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.
The demonstration that, compared to mpMRI alone, the use of PET/MRI with 18F-PSMA has a superior diagnostic accuracy in detecting men with csPCa will strongly support the inclusion of 18F-PSMA as pre-biopsy triage test, in addition to mpMRI in daily clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
研究组 & 干预措施
18F-PSMA-1007
All patients undergo the same experimental procedure
干预措施: 18F-PSMA-1007 (Drug)
结局指标
主要结局
To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone
时间窗: Biopsy at day 90 (+/-90)
The number of csPCa missed by PET and MR imaging when read independently
To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of csPCa
时间窗: Biopsy at day 90 (+/-90)
Diagnostic accuracy measured with sensitivity, specificity, positive and negative predicted value
To report the change in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET, and consequently the proportion of unnecessary biopsies potentially spared.
时间窗: Biopsy at day 90 (+/-90)
Only in patients with positive mpMRI and negative 18F-PSMA PET: The proportion of clinically insignificant PCa
次要结局
未报告次要终点
研究者
Maria Picchio
Associate Professor
IRCCS San Raffaele