The Addictive Diagnostic Value of Apparent Diffusion Coefficients to PI-RADS 3-5 of Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Evaluate whether ADC values can improve the diagnostic capacity of bpMRI for clinically significant prostate cancer (csPCa) (Gleason score ≥ 3+4, ISUP grade ≥ 2) in patients with PI-RADS 3-5.
研究概览
简要总结
The goal of this study is to evaluate the diagnostic value of different ADC values (incuding ADCmin, ADCmean, ADCratio and ADCrange) of bpMRI in patients with PI-RADS 3-5. The main aim is to evaluate whether different ADC values improve the diagnosis of clinically significant prostate cancer (Gleasonscore≥3+4, ISUP grade ≥2) and any-grade prostate cancer (Gleasonscore≥3+3, ISUP grade ≥1).
详细描述
The study is conducted with suspected prostate cancer. Patients with PI-RADS scores of 3-5 after completing prostate bpMRI chose to undergo prostate biopsy. Before patients undergo prostate biopsy, researchers will collecte information on age, BMI, tPSA, f/PSA, PV, PSAD, ADCmean, ADCmin, ADCmax, ADCnormal, maximum lesion diameter, location of major lesions, and so on. For prostate biopsy, systematic prostate biopsy ± bpMRI cognitive fusion targeted prostate biopsy will be completed under the conditions permitted by physical condition, and Gleason score will be clearly given by pathologists if the final diagnosis is prostate cancer. In this study, the pathological result is regarded as the gold standard. ROC curve, area under curve, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio and other indicators of diagnostic test were calculated. Relevant conclusions are finally drawn by comparing the diagnostic capacity of different ADC values for prostate cancer. Meanwhile, binary logistic regression analysis will also conduct the Odds ratios (ORs) and 95% confidence intervals (CIs) will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •The patient met at least one indication of prostate biopsy (Chinese expert consensus on prostate biopsy (2022 edition) https://rs.yiigle.com/cmaid/1442948 );
- •Serum PSA test was completed in the patient with tPSA < 100 ng/ml;
- •Primary prostate tumor lesion, no history of other tumors;
- •Completed 3.0T bpMRI examination, PI-RADS score ≥3 score, the image is clear and readable;
- •Patients fully understand the relevant contents of the study and voluntarily sign the informed consent.
排除标准
- •The patient has contraindications for MRI;
- •PI-RADS 1-2 of bpMRI;
- •The patient had contraindications to prostate biopsy or explicitly refused biopsy;
- •bpMRI indicated that the patient had multiple lymph nodes or bone metastases;
- •Previous prostate-related surgery;
- •The patient refused to sign the informed consent.
结局指标
主要结局
Evaluate whether ADC values can improve the diagnostic capacity of bpMRI for clinically significant prostate cancer (csPCa) (Gleason score ≥ 3+4, ISUP grade ≥ 2) in patients with PI-RADS 3-5.
时间窗: through study completion, an average of 1 month
csPCa means Gleason score ≥ 3+4， ISUP grade ≥ 2. Evaluation indexes: ROC curves and AUC value (95%CI) , Sensetivity, Specificity, Positive predictive value and negative predictive value. The odds ratios (ORs) and 95% confidence intervals in logistic analysis.
次要结局
- Evaluate whether ADC values can improve the diagnostic capacity of bpMRI for any-grade prostate cancer (PCa) (Gleason score ≥ 3+3, ISUP grade ≥ 1) in patients with PI-RADS 3-5.(through study completion, an average of 1 month)
- Evaluate the diagnostic capacity of different PI-RADS scores combined with different ADC cut off values for csPCa(through study completion, an average of 1 month)
- Compare the diagnostic value of different ADC values for csPCa in patients with 3-5 points of PI-RADS.(through study completion, an average of 1 month)
研究者
XiaoJun
Professor, Chief Physician
Anhui Provincial Hospital