A novel urinary long non-coding RNA transcript improves diagnostic accuracy in patients undergoing prostate biopsy

Area of Science:

• Biomarkers
• Molecular Diagnostics
• Urology

Background:

• Prostate cancer (PCa) detection often relies on biomarkers like PCA3.
• A novel long non-coding RNA (LncRNA), FR0348383, is upregulated in over 70% of PCa cases.
• This study evaluates the diagnostic utility of urinary FR0348383 in men undergoing prostate biopsy.

Purpose of the Study:

• To assess the diagnostic accuracy of urinary FR0348383 for prostate cancer detection.
• To evaluate the FR0348383 score in men with elevated PSA and/or abnormal DRE results.
• To determine if FR0348383 can improve PCa diagnosis, particularly in the 'grey zone' PSA range.

Main Methods:

• Prospective collection of first-catch urine samples post-DRE before prostate biopsies.
• Quantification of urine FR0348383 and PSA mRNA using quantitative real-time PCR.
• Calculation of the FR0348383 score (PSA mRNA/FR0348383 mRNA × 1000) and evaluation using logistic regression and decision curve analysis.

Main Results:

• The FR0348383 score was an independent predictor of PCa, correlating with increased biopsy positivity.
• In patients with PSA 4.0-10.0 ng/ml, the FR0348383 score showed superior diagnostic performance (AUC 0.815) compared to PSA, %free PSA, and PSA Density.
• Utilizing a 30% probability threshold, the FR0348383 score could potentially avoid 52% of unnecessary biopsies without missing high-grade cancers.

Conclusions:

• Urinary FR0348383 transcript is a promising novel biomarker for PCa detection with significant diagnostic value.
• The FR0348383 score is particularly effective in the 'grey zone' PSA cohort, aiding in clinical decision-making.
• Clinical application of the FR0348383 score may reduce unnecessary prostate biopsies and enhance PCa diagnostic specificity.