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The role of prostate-specific antigen density and negative multiparametric magnetic resonance imaging in excluding prostate cancer for biopsy-naïve men: clinical outcomes from a high-volume center in China


1 Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu 610041, China
2 Department of Ultrasound, West China Hospital, Sichuan University, Chengdu 610041, China
3 Department of Radiology, West China Hospital, Sichuan University, Chengdu 610041, China
4 Department of Pathology and Laboratory of Pathology, State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Chengdu 610041, China

Correspondence Address:
Lu Yang,
Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu 610041
China
Qiang Wei,
Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu 610041
China
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/aja202220

This study aimed to assess the role of prostate-specific antigen density (PSAD) and negative multiparametric magnetic resonance imaging (mpMRI) in predicting prostate cancer for biopsy-naïve men based on a large cohort of the Chinese population. From a prostate biopsy database between March 2017 and July 2021, we retrospectively identified 240 biopsy-naïve patients with negative prebiopsy mpMRI (Prostate Imaging Reporting and Data System version 2 [PI-RADS v2] score <3). Logistic regression analysis was performed to select the potential predictors for clinically significant prostate cancer (csPCa). Receiver operating characteristic (ROC) curve analysis and area under the ROC curve (AUC) were performed to assess the diagnostic accuracy. The negative predictive values of mpMRI in excluding any cancer and csPCa were 83.8% (201/240) and 90.8% (218/240), respectively. ROC curve analysis indicated that PSAD was the most promising predictor, with an AUC value of 0.786 (95% confidence interval [CI]: 0.699–0.874), and multiparametric logistic regression analysis confirmed that higher PSAD remained a significant marker for predicting csPCa (odds ratio [OR]: 10.99, 95% CI: 2.75–44.02, P < 0.001). Combining negative mpMRI and PSAD below 0.20 ng ml−2 obviously increased the predictive value in excluding PCa (91.0%, 101/111) or csPCa (100.0%, 111/111). If a PSAD below 0.20 ng ml−2 was set as the criterion to omit biopsy, nearly 46.3% of patients (463 per 1000) with negative mpMRI could safely avoid unnecessary biopsy, with approximately 4.2% of patients (42 per 1000) at risk of missed diagnosis of PCa and no patients with csPCa missed. A PI-RADS v2 score <3 and a PSAD <0.20 ng ml−2 could be potential criteria for the Chinese population to omit prompt biopsy safely.


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