Reliability of Negative Prostate MRI for Biopsy Decision‐Making in the Male Han Chinese Population

TL;DR

This study evaluates how reliable negative prostate MRI results are for avoiding unnecessary biopsies in Chinese men, finding that certain prostate volume and PSA density thresholds can improve reliability.

Contribution

The study identifies specific clinical parameters that enhance the negative predictive value of prostate MRI in the Han Chinese population.

Findings

A prostate volume >55.25 mL, PSAD <0.100 ng/mL², or PSADadj <7.24 ng/mL can increase MRI's negative predictive value to 100%.

PSAD <0.205 ng/mL² and PSADadj <24.97 ng/mL improve MRI's NPV to 97.6% and 92.6%, respectively.

The study highlights ethnic-specific factors affecting prostate cancer diagnosis in Han Chinese men.

Abstract

Multiparametric magnetic resonance imaging (mpMRI) has been widely utilized in clinical practice for identifying clinically significant prostate cancer (csPCa). Although mpMRI demonstrates a pooled negative predictive value (NPV) of 90%, additional clinical parameters require evaluation to enhance this metric specifically for the Chinese population—given the rising incidence of PCa in China, as well as ethnic differences in average prostate volume (PV) and chronic prostatitis prevalence that may impact mpMRI’s diagnostic performance.

A retrospective analysis was conducted on 543 patients who underwent transrectal ultrasound‐guided prostate biopsy at Beijing Tsinghua Changgung Hospital between November 2014 and March 2025. After applying exclusion criteria, 412 patients were enrolled, all of whom had completed prebiopsy mpMRI within 1 month prior to biopsy. Patients were stratified into four groups based on the results of MRI examination and the pathological outcomes of biopsy: MRI (−) PCa (−), MRI (+) PCa (−), MRI (−) PCa (+), and MRI (+) PCa (+) groups. Multivariate logistic regression analyses were used to assess the odd ratios (ORs) of potential predictors for csPCa, comparing the MRI (−) PCa (+) and MRI (−) PCa (−) groups. Receiver operating characteristic curves were generated to analyze the predictive values of total PSA (tPSA), free PSA (fPSA), free‐to‐total (f/t) PSA, PV, PSA density (PSAD), and adjusted PSAD (PSADadj, defined as PSAD × weight) for csPCa in patients with negative MRI.

The patient distribution was as follows: MRI (−) PCa (−) group: 27.9% (115/412), MRI (+) PCa (−) group: 36.9% (152/412), MRI (−) PCa (+) group: 2.4% (10/412), and MRI (+) PCa (+) group: 32.8% (135/412). The NPV of MRI for csPCa was 92%. Multivariate analyses indicated that PV was negatively associated with the presence of csPCa (OR = 0.940, 95% CI: 0.896–0.986, p = 0.012), while PSAD and PSADadj were positively associated with csPCa occurrence (OR = 10.288, 95% CI: 1.569–67.46, p = 0.015; OR = 1.027, 95% CI: 1.001–1.053, p = 0.043, respectively). For MRI‐negative patients, PV > 55.25 mL (sensitivity = 100%, specificity = 63.2%), PSAD < 0.100 ng/mL2 (sensitivity = 100%, specificity = 25.4%), or PSADadj < 7.24 ng/mL (sensitivity = 100%, specificity = 28.1%) enhanced MRI’s NPV to 100%, while PSAD < 0.205 ng/mL2 (sensitivity = 77.8%, specificity = 71.9%) and PSADadj < 24.97 ng/mL (sensitivity = 55.6%, specificity = 90.4%) improved NPV to 97.6% and 92.6%, respectively.

In Chinese men with negative prostate MRIs, PV > 55.25 mL, PSAD < 0.100 ng/mL2, or PSADadj < 7.24 ng/mL may elevate mpMRI’s NPV from 92% to 100%, enabling safe avoidance of unnecessary biopsies. Prospective multicenter validation is required to confirm these findings.

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