The experimental arm receiving diagnosis from serum RNA combination

The primary outcome is to investigate a plasma-exosome RNA panel in diagnosing clinically significant prostate cancer (csPCa) and evaluate its sensitivity and specificity in diagnosing csPCa.

Descriptive statistics were calculated and presented as the frequency (percentage) for categorical variables, the mean (standard deviation) for continuous variables with a normal distribution, and the median (quartile) for continuous variables with a skewed distribution. Two-sample t-tests were used to assess continuous variables with a normal distribution, and the Wilcoxon signed-rank test was used to assess continuous variables with a skewed distribution. The Mann-Whitney U test was used to compare means from two samples. The correlation between two samples was analyzed by Spearman's ρ test. The receiver operating characteristic (ROC) curve was used to determine the cutoff value of exo-RNA panel for diagnosing patients with csPCa.

The secondary outcome is to evaluate the positive predictive value (PPV), negative predictive value (NPV) and accuracy of exo-RNA panel in detection of csPCa; and compare the diagnostic performance of the plasma-exosome RNA panel with other imaging methods or blood tests in identifying prostate cancer patients; Whether the exo-RNA panel could predict the PCa patients with higher Gleason score (GS).

The comparison between diagnostic performance of exo-RNA panel and other imaging or blood tests is performed in ROC curves. The ICC analysis was performed by reliability analysis. All statistical analyses were conducted using IBM SPSS statistics software, version 23.0 (IBM, Inc., Chicago, IL, USA) and GraphPad Prism software, version 8.0 (GraphPad Software, Inc., La Jolla, CA, USA).