NOVEL SOLUTION BASED ON DETECTION OF MIRS-410-3P AND 141-5P FOR DIAGNOSTIC OF PROSTATE CANCER EVOLUTION

Prostate cancer (PCa) remains the most frequently diagnosed malignancy in men and the second leading cause of cancer-related mortality worldwide. Population-based prevention and screening programmes have improved early detection rates; however, current diagnostic pathways—largely driven by prostate-specific antigen (PSA) testing and imaging—still suffer from limited sensitivity and specificity. This limitation contributes to substantial rates of unnecessary biopsies, overdiagnosis and overtreatment, highlighting the need for more accurate molecular stratification tools.

In recent years, circulating microRNAs (miRNAs) have emerged as promising biomarkers for cancer diagnosis, risk reclassification, prediction of tumour progression and treatment response. Among them, miR-410-3p and miR-141-5p have been consistently implicated in prostate cancer biology. Previous studies in tumour tissues and prostate cancer cell lines have demonstrated that elevated miR-410-3p expression correlates with discordant clinical scenarios in which PSA levels fail to match biopsy, surgical or digital rectal examination findings, as well as with poor patient prognosis. In parallel, miR-141-5p exhibits complementary behaviour, supporting the rationale for a dual-biomarker approach based on relative expression patterns rather than single-marker quantification.

Mechanistically, miR-410-3p has been shown to exert oncogenic activity through downregulation of PTEN, leading to activation of the AKT/mTOR signalling pathway. Notably, divergent expression dynamics of miR-410-3p have been reported between tumour tissues, cancer cell lines and peripheral blood, reinforcing the value of combined assessment with miR-141-5p. Large cohort studies (n > 500) have confirmed upregulation of miR-141-5p in prostate cancer patients at both epithelial and stromal levels, while concomitant reduction of circulating miR-410-3p has been associated with increased risk of biochemical recurrence.

In this study, we present the design, molecular configuration and preclinical evaluation of a novel RTqPCR-based diagnostic system that leverages residual blood volumes routinely discarded after PSA testing. The system enables semi-quantitative, parallel detection of miR-410-3p and miR-141-5p in plasma, providing a non-invasive molecular readout of prostate cancer progression and recurrence risk. The results support the feasibility of this approach as a complementary diagnostic tool with the potential to reduce reliance on invasive procedures such as biopsy, surgery and digital rectal examination, while improving molecular precision in prostate cancer management.