The Performance of MRI Prostate in Men With Different Prostate Health Index (Phi) Values: Can we Save Some MRI Scans?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- In men with higher risk of significant prostate cancer, proportion of men with abnormal MRI at different Prostate Health Index (phi) ranges
研究概览
简要总结
This study is to investigate, in a larger cohort of consecutive men, the proportion of abnormal MRI prostate in different phi ranges, and the cancer detected in Chinese men with abnormal MRI. This study aims to evaluate whether MRI prostate can be omitted in men with lower suspicion of prostate cancer.
详细描述
This is a prospective cohort study recruiting consecutive men with elevated blood test PSA 4-10 ng/mL, normal prostate on digital rectal examination, and result for blood Prostate Health Index (phi) known. A multi-parametric MRI prostate with contrast will be performed in all subjects. MRI prostate will be reported according to PI-RADS (Prostate Imaging-Reporting and Data Systems) v2.1 recommendations[10] and scored from 1 to 5. A PI-RADS score of 3-5 is considered abnormal. The proportion of abnormal MRI in different phi ranges (primary outcome) will be compared.
The subjects will be offered a prostate biopsy according to usual clinical indications in our hospital: In men with phi >35 (higher risk of significant prostate cancer), prostate biopsy (systematic biopsy, plus MRI-guided if abnormal MRI) will be offered. In men with phi < 35 (lower risk of prostate cancer), prostate biopsy (systematic plus MRI-guided) will be offered only if MRI is abnormal.
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
- •Ethnically Chinese Men ≥18 years of age
- •Clinical suspicion of prostate cancer and indicated for prostate biopsy
- •Serum Prostate-specific antigen (PSA) 4-10 ng/mL
- •Serum Prostate health index (phi) result available
- •Normal Digital rectal examination
- •Able to provide written informed consent
排除标准
- •Past or current history of prostate cancer
- •On 5-alpha reductase inhibitor in the past 6 months (e.g. Finasteride, Dutasteride)
- •MRI prostate performed in past 5 years
- •Contraindicated to undergo MRI scan (e.g. pacemaker in-situ, claustrophobia, estimated glomerular filtration rate < 50ml/min in serum renal function test within 3 months)
- •Contraindicated for prostate biopsy (e.g. uncorrectable coagulopathy, active infection
结局指标
主要结局
In men with higher risk of significant prostate cancer, proportion of men with abnormal MRI at different Prostate Health Index (phi) ranges
时间窗: Baseline (only one-time point)
In men with higher risk (phi\>35) of significant prostate cancer), proportion of men with abnormal MRI.
In men with lower risk of significant prostate cancer, proportion of men with abnormal MRI at different Prostate Health Index (phi) ranges
时间窗: Baseline (only one-time point)
In men with lower risk (phi\<35) of significant prostate cancer), proportion of men with abnormal MRI.
次要结局
- Proportion of low risk group diagnosis of clinically significant prostate cancer with abnormal MRI(Baseline (only one-time point))
- Sensitivity of various phi cutoffs to predict PI-RADS score ≥3 in MRI prostate(Baseline (only one-time point))
- Sensitivity of various phi cutoffs to predict PI-RADS score ≥4 in MRI prostate(Baseline (only one-time point))
研究者
CHIU Ka Fung Peter
Associate Professor
Chinese University of Hong Kong