Analysis of missed diagnosis and risk factors in patients with negative initial prostate biopsy with PI-RADS score>3 / 中华泌尿外科杂志

ABSTRACT

Objective:To analyze the risk of missed diagnosis in patients with PI-RADS score>3 and negative prostate initial biopsy and to explore its risk factors.Methods:The clinical data of 268 patients with negative prostate biopsy in Northern Jiangsu People's Hospital from May 2013 to December 2018 were retrospectively analyzed. The patients were divided into observation group (PI-RADS score>3) and control group (PI-RADS score≤ 3) according to different PI-RADS scores. There were insignificant differences in age [(67.4(60.0, 74.0)years and 65.6(66.5, 72.0)years], prostate volume of initial biopsy [62.4(40.0, 72.0)ml and 60.8(38.0, 77.0)ml], biopsy cores [ 20.6(18.0, 22.0)cores and 20.4(18.0, 22.0)cores] between the observation group (n=124) and the control group(n=144)(all P>0.05). But there were significant differences in PSA [17.5(6.5, 23.0)ng/ml and 11.5(6.3, 12.0)ng/ml], PSAD[0.316(0.128, 0.363)ng/ml 2 and 0.211(0.106, 0.256)ng/ml 2], prostate inflammation of the initial biopsy [70 (56.5%) and 32 (22.2%)] between the observation group and the control group(all P<0.05). According to the follow-up results after the initial biopsy, the two groups of repeated biopsy were compared.Furthermore, Logistic regression was used to conduct univariate and multivariate analysis to explore the risk factors of patients with PI-RADS>3 for positive repeated biopsy. At the same time, the receiver operating characteristic curve (ROC curve) was used to analyze the accuracy of the risk factors. Results:There were significant differences in repeated biopsy rate [ 27.4%(34/124)and 14.6%(21/144)], CsPCa detection rate[ 41.4%(14/34) and 4.8%(1/21)]between the observation group and the control group(all P<0.05). The positive rate of repeated biopsy in the observation group (41.1%) was higher than that in the control group (23.8%), but there was no statistical difference ( P=0.248). The risk of positive repeated biopsies in the observation group was 2.24 times than that in the control group. Univariate analysis found repeated biopsy PSA ( P =0.02, OR=1.438, 95% CI 1.161-1.896), PSA ratio (repeated biopsy PSA/initial biopsy PSA) ( P=0.011, OR=10.087, 95% CI 1.714-59.36) were risk factors for positive of repeated biopsy in patients with PI-RADS score >3. Multivariate analysis also found that repeated biopsy PSA ( P=0.017, OR=1.15, 95% CI 1.076-2.123), PSA ratio ( P=0.032, OR=10.2, 95% CI 0.883-116.168) were risk factors for positive repeated biopsy. ROC curve analysis, the accuracy of repeated biopsy PSA (AUC=0.971, P<0.001, 95% CI 0.926-1.000), PSA ratio (AUC=0.839, P=0.001, 95% CI0.707-0.971) to predict positive of repeated biopsy were high. The cut-off values were 21.3 ng/ml and 1.4, respectively. The accuracy was higher when combines repeated biopsy PSA with PSA ratio (AUC=0.993, P<0.001, 95% CI 0.974-1.000). Conclusions:Patients with negative PI-RADS score > 3 have a higher risk of missed diagnosis of CsPCa than those with PI-RADS score≤3. When PSA>21.3 ng/ml and PSA ratio>1.4 during follow-up, the possibility of missed diagnosis in the initial biopsy is high.