Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference
研究概览
简要总结
To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference
详细描述
To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference
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
- •age >18 years
- •male patient scheduled for cystoprostatectomy as treatment of muscle invasive bladder cancer (clinical T2-T3, any N) or high risk non-muscle invasive bladder cancer (pT1 or CIS)
- •no known diagnosis of prostate cancer
- •no contraindication to undergo multiparametric MRI
- •Signed written informed consent prior to any screening procedures being performed
- •Patient affiliated to the ''National security'' regimen or beneficiary of this regimen
排除标准
- •allergy against MR contrast media
- •diagnosis or previous treatment of prostate cancer
- •severe renal insufficiency (GFR <30ml/min)
- •Bladder cancer infiltrating the prostate (T4)
- •Pelvic metallic implants such as hip prosthesis
- •Patients scheduled for cystoprostatectomy with prostate capsule sparing
- •Patients unable to provide informed consent
- •Patients having a prostate biopsy <6 month
研究组 & 干预措施
mpMRI
mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen
干预措施: mpMRI (Device)
结局指标
主要结局
Negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference
时间窗: From the date of mpMRI exam (Day-1) to the date pathology report of Day 0 surgery is obtained (an average of 7 days)
The true negative and false negative rates of mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen as a reference in patients with no previous diagnosis of prostate cancer.
次要结局
未报告次要终点