| Part Ⅰ the application value of PI-RADS version 2.1 scoring system in detecting transition zone prostate cancerPurpose:Evaluation the diagnostic value of PI-RADS v2.1 in transition zone(TZ)prostate cancer.Methods:the pathological and clinical data of patients with prostate diseases admitted to the Second Affiliated Hospital of Soochow University from March 2016 to October 2018 were analyzed retrospectively.all patients underwent magnetic resonance imaging examination.Ultrasound-guided transrectal system biopsy(10+X)and MRI-TRUS fusion biopsy were the gold standard.Two radiologists used PI-RADS v2.1 and PI-RADS v2 to evaluate MRI of each patient independently,and to calculate the sensitivity,specificity,positive predictive value and negative predictive value of the diagnosis,the consistency and receiver operating characteristic(ROC)were used in statistical tests.Results:A total of 584 patients were enrolled in the study,including 111 Gleason≥1 patients and 473 Gleason=0 patients.Age,f-PSA,t-PSA,f/tPSA of Gleason≥1 patients were 74.3±7.7,1.89(1.06,4.48),16.1(8.71,45.56),0.12(0.08,0.17),respectively.Age,f-PSA,t-PSA,f/tPSA of Gleason=0 patients 69.3 ± 8.3,1.39(0.889,2.43),9.56(6.28,15.53),0.15(0.11,0.21),respectively.The positive predictive value(PPV)was 51.5%and the negative predictive value(NPV)was 99.4%,when reader 1 scored with PI-RADS V2.The PPV was 36.3%and the NPV was 94.8%when PI-RADS V2.1 was used.When reader 2 scored with PI-RADS v2,the PPV and the NPV were 67.7%and 94.5%respectively.The PPV was 34.2%and the NPV was 91.6%for the first score of PI-RADS V2.1.The PPV of the second score was 47.6%,and the NPV was 96.6%.For reader 1,compared with PI-RADS version 2,version 2.1 had higher sensitivity(85%vs.79%,P=0.03),lower specificity(65%vs.83%,P<0.001),and lower area under the curve(AUC)(0.749 vs.0.809,P<0.001).For Reader 2(first attempt),compared with PI-RADS version 2,version 2.1 had lower specificity(67%vs.91%,P<0.001)and lower AUC(0.702 vs.0.844,P<0.001).For Reader 2(second attempt),compared with PI-RADS version 2,version 2.1 had higher sensitivity(88%vs.78%,P<0.001)and lower specificity(77%vs.91%,P<0.001).The kappa value of the two readers with PI-RADS v2 and v2.1 were 0.516 and 0.452,respectively.The kappa between the two attempts for Reader 2 was 0.321.Conclusion:These results suggest that PI-RADS version 2.1 might improve the detection of prostate cancers in the transition zone compared with PI-RADS version 2 but that it might cause higher numbers of biopsies because of lower specificity.Part Ⅱ Can Combination PI-RADS v2.1 and clinical indicators improve diagnostic performance for transition zone clinically significant prostate cancer in patients with PSA 4-20 ng/ml?Purpose:To evaluate diagnostic performance of the combination of Prostate Imaging Reporting and Data System version 2.1(PI-RADS v2.1)score based on biparametric magnetic resonance imaging(bp-MRI)and clinical information for the assessment of clinically significant prostate cancer(cs-PCa)in transition zone(TZ)patients with serum prostate specific antigen(PSA)levels of 4-20 ng/ml.Methods:The imaging,pathological and clinical data of 333 TZ patients with PSA 4-20ng/ml,examined by bp-MRI from January 2016 to March 2020 in the Second Affiliated Hospital of Soochow University were analyzed retrospectively.Two radiologists used PI-RADS v2.1 to evaluate images independently and "double-blind" method.The clinical data included age,t-PSA,f/tPSA,PV and PSAD.Ultrasound-guided transrectal system biopsy and MRI-TRUS fusion biopsy were used as the gold standard.Multivariate logistic regression analysis was used to determine independent predictors.Receiver operating characteristic(ROC)curve and DeLong’s test were performed to compare the diagnostic performance.Results:PI-RADS v2.1 score and PSA density(PSAD)were independent predictors for TZ cs-PCa in patients with PSA 4-20 ng/mL.0.9%of PI-RADS v2.1 score of 1 or 2 had cs-PCa.The cs-PCa detection rate was 8.6%for PSAD<0.15 ng/ml/ml and 3.7%for PSAD 0.15-0.29 ng/mL/mL in patients with PI-RADS v2.1 score of 3.A PI-RADS v2.1 score of>3 and PSAD<0.15 ng/ml/ml had no cs-PCa.When PI-RADS v2.1 score and PSAD were combined,a PI-RADS v2.1 score>3 and PSAD ≥ 0.30 ng/ml/ml had the highest cs-PCa detection rate(66.7%)in TZ patients with PSA levels of 4-20 ng/ml.It showed the highest AUC in the combination of PI-RADS v2.1 score and PSAD(AUC=0.910),which was significantly higher than that in PI-RADS v2.1 score(AUC=0.889,P=0.039)or PSAD(AUC=0.803,P<0.001).Conclusion:For TZ Patients with PSA 4-20 ng/ml,PI-RADS v2.1 score ≤2 may avoid unnecessary biopsy,regardless of the PSAD value.PI-RADS v2.1 score≥ 3 may avoid unnecessary biopsy,combining with the PSAD value.PI-RADS v2.1 score based on bp-MRI combined with PSAD could significantly improve its diagnostic performance.Part Ⅲ:Application of nomogram in the prediction of clinically significant PSA 4-20ng/ml TZ PCaPurpose:Construction the prediction model of PSA 4-20ng/ml TZ cs-PCa based on bp-MRI PI-RADS V2.1 score combined with PSAD,the application value of the model was evaluated.Methods:From January 2016 to March 2020,the imaging,case history and clinical data of patients undergoing prostate MRI examination and transrectal ultrasound guided prostate biopsy in the Second Affiliated Hospital of Soochow University were analyzed retrospectively.After inclusion and exclusion criteria screening,333 patients were enrolled,and two physicians performed independent "double-blind" analysis of MRI images based on PI-RADSv2.1.According to the ratio of 7:3,233 cases(70%)in the training group and 100 cases(30%)in the validation group were randomly divided into two groups.The training group was used to build the model,and the validation group was used to validate the model.The gold standard were the results of ultrasound-guided transrectal system biopsy(10-needle+X method)and targeted MRI-TRUS fusion biopsy.SPSS 22.0,medical 15.2.2 and R3.6.2 were used to analyze the data.First,the training group was analyzed by univariate and multivariate logistic regression,the independent prediction index is input into R language software to construct nomogram.Internal validation of nomogram by bootstrap method.The calibration degree or goodness of fit of the model is evaluated by drawing the calibration curve between the predicted results and the actual results.Clinical application value of evaluation model by drawing decision curve.All P values were bilateral,P<0.05 was statistically significant.Results:In the training group,there were 46 cases of PCa,including 22 cases of cs-PCa and 24 cases of Lower Grade PCa.There were 187 cases of non-cancerous Lesions.In the training group,the age,t-PSA,f/t-PSA,PSAD,PV and PI-RADS V2.1 scores in the cs-PCa group were significantly different from those in the low-grade PCa and non-cancer group(p<0.05),the PSAD,PV and PI-RADS V2.1 scores in cs-PCa group were significantly different from those in low-grade PCa and non-cancer group(p<0.05),but there were no significant differences in age,t-PSA,f/tPSA between the two groups(p<0.05).Age,f/t-PSA,PSAD and PI-RADS V2.1 scores in the training group were analyzed by multiple logistic regression.Multivariate logistic regression analysis showed that PSAD and PI-RADS V2.1 scores were independent predictors of PS A 4-20ng/ml TZ cs-PCa(p<0.05).Nomogram validation showed that the AUC of the training group and the validation group were 0.938 and 0.878,respectively.The prediction curves in the training group and the validation group were in good agreement with the actual curves.When the prediction probability was in the range of 0.3-0.5,the prediction curves were in agreement with the actual curves.The decision curve shows that the threshold probability of the training group is greater than 0.3 and the threshold probability of the validation group is greater than 0.4,compared with the single index(PI-RADS V2.1 score or PSAD),the prediction model based on PI-RADS V2.1 score and PSAD showed higher net benefit,which indicated that the model had good clinical validity.Conclusion:Based on bp-MRI,PI-RADS v2.1 score combined with PSAD can predict the PSA 4-20ng/ml TZ cs-PCa with better accuracy,consistency and clinical validity. |
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