Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sensitivity, specificity and accuracy of MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy
研究概览
简要总结
This study will enroll 200 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml or abnormal digital rectal examination.
Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 3 Tesla (T) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer.
Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS biopsy.
Moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer.
详细描述
Specific aims of the current study are as follows:
i) To determine the sensitivity, specificity and accuracy of a novel rapid anatomical MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy
ii) To determine the sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer
iii) To develop statistical model for diagnosis of prostate cancer incorporating findings of a novel rapid MRI/DWI and selected biomarkers
iv) To assess the applicability of TRUS guided prostate biopsy based on MRI finding in patient with no previous prostate biopsy
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age: 40 to 85 years
- •Language spoken: Finnish
- •Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to 25 ng/ml in two following measurements and/or abnormal digital rectal examination
- •Mental status: Patients must be able to understand the meaning of the study
- •Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff
排除标准
- •previous prostate biopsies
- •previous diagnosis of prostate carcinoma
- •previous prostate surgeries, e.g. TURP (transurethral prostatic resection)
- •symptomatic of acute prostatitis
- •contraindications for MRI (cardiac pacemaker, intracranial clips etc)
- •uncontrolled serious infection
- •claustrophobia
- •any other conditions that might compromise patients safety, based on the clinical judgment of the responsible urologist
研究组 & 干预措施
MRI and biomarkers
Prostate MRI. Blood and urine biomarkers. Both prior to biopsy. Tissue samples during prostatectomy.
干预措施: Prostate MRI (Other)
结局指标
主要结局
Sensitivity, specificity and accuracy of MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy
时间窗: Baseline (MRI prior to prostate biopsy)
次要结局
- Sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer(Baseline and during procedure)
研究者
Hannu Aronen
Professor, Chief Physician
Turku University Hospital