Evaluation of Diagnostic Value of 3-T MRI in Suspected Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Number of Prostate Cancer Diagnoses in MRI and no MRI Groups
研究概览
简要总结
The purpose of the study is to evaluate the usefulness of 3-T magnetic resonance imaging (MRI) in the evaluation of suspected prostate cancer. Men with suspected prostate cancer based on serum prostate-specific antigen antigen (PSA) value are included. Men are randomized to pre-biopsy MRI or no MRI groups in ratio 1:1. Standard transrectal ultrasound guided biopsies will be taken in addition to extra biopsies from lesions suspicious based on MRI evaluation. Hypothesis is that more prostate cancers will be found after MRI evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 72 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Suspected prostate cancer based on PSA value (total PSA 2,5-10 ng/ml and PSA free to total ratio <=0.15, or total PSA 10-20 ng/ml)
- •PSA and serum creatinine measurement less than 60 days before transrectal ultrasound-guided prostate biopsies
- •No evidence of PSA increase by non-cancerous factors (catheterization, bladder stones, urinary tract infection including bacterial prostatitis)
排除标准
- •Previous prostate biopsies
- •Previous prostate surgery
- •Contraindication for MRI (such as pacemaker or inner ear implant)
- •Claustrophobia
- •Estimated glomerular filtration rate (eGFR) <40 ml/min
- •Suspected clinical T3-T4 prostate cancer based on digital rectal examination
- •Contraindication for transrectal ultrasound-guided prostate biopsies
- •body mass index >30
研究组 & 干预措施
no MRI
No MRI before prostate biopsies
MRI done
Subjects with MRI prior prostate biopsies
干预措施: magnetic resonance imaging, Siemens (Device)
结局指标
主要结局
Number of Prostate Cancer Diagnoses in MRI and no MRI Groups
时间窗: at the end of the study (up to 1 year)
The number of patients with confirmed prostate cancer among men with MRI performed before biopsies are compared to the number of patients with prostate cancer confirmed in prostate biopsies without MRI. The number patients with prostate cancer are counted as total from cancers detected in random biopsies and in biopsies targeted based on suspicious MRI findings in MRI group, and from random biopsies in no MRI group.
次要结局
- Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups(at the end of the study (up to 1 year))
- Number of Positive Biopsies in MRI and no MRI Groups(at the end of the study (up to 1 year))
研究者
Markku Vaarala, MD, PhD
MD, PhD
University of Oulu