TEST:

SelectMDx

This case illustrates the importance of diagnostic vigilance and multimodal correlation in a minimally symptomatic patient, particularly when persistent clinical findings are not fully explained by the initial diagnosis. The findings should be interpreted as illustrative and cannot be generalized beyond the single-case context.

Despite challenges in assay standardization, validation, cost, and ethical implementation, the convergence of genomics, liquid biopsy, and AI technologies marks a transformative step toward personalized prostate cancer management. To distinguish clinically validated tools from emerging candidates, biomarkers are discussed according to their level of evidence and clinical readiness.

Additionally, the review addresses key genetic alterations implicated in prostate carcinogenesis, including mutations in BRCA1/2, HOXB13, and PTEN deletions, as well as changes in the androgen receptor pathway. By evaluating recent advancements and applications of these biomarkers, this review aims to enhance understanding of their role in improving early diagnosis, prognosis, and personalised management of prostate cancer.

Molecular and genetic biomarkers show promise for improving AS by reducing diagnostic misclassification and enhancing prediction of progression. Future research should define clinically relevant cut-offs, clarify integration with MRI, and evaluate longitudinal use. Demonstrating utility in contemporary cohorts could enable the development of biomarker-guided, personalised AS that maintains safety while minimising harm.

This narrative review demonstrates that although PSA remains the mainstay of prostate cancer diagnosis, emerging molecular and genomic biomarkers are enhancing diagnostic specificity, refining risk stratification, and enabling more personalized patient care. The integration of routinely used and novel biomarkers can improve early detection, optimize treatment decisions, and ultimately improve outcomes of prostate cancer patients.

Its high NPV avoids unnecessary biopsies and their associated morbidity. While integrating SelectMDx with mpMRI provides new diagnostic insights, the molecular test revealed superior accuracy when used alone, confirming its importance in precision medicine.

Therapeutic approaches-antagomirs, sponges, miRNA masks, and CRISPR editing-show preclinical promise, while chemical modifications [peptide nucleic acids (PNAs), locked nucleic acids (LNAs), C2' modifications] improve stability and delivery but remain limited by biodistribution, tissue penetration, off-target effects, and immunogenicity. In conclusion, standardized workflows and multicenter validation, integrated with clinical and imaging data, are essential to translate miRNA-based tools into precision PC management.

SelectMDx has proven to be a valuable tool in the risk stratification of clinically significant prostate cancer, contributing to improved clinical decision-making and reducing unnecessary biopsies. However, further studies are needed to validate its performance across different populations.

The test demonstrated a sensitivity of 57.14%, a specificity of 81.82%, a positive predictive value of 40% and a negative predictive value of 90%, with an overall diagnostic accuracy of 77.5%. While age emerged as the only independent predictor in multivariate analysis, SelectMDx showed a strong potential to exclude malignancy and support more selective biopsy strategies.

Current evidence supports the multidisciplinary integration of these biomarkers to overcome the limitations of PSA, improve biopsy decision-making, better distinguish indolent from aggressive tumors, and optimize therapeutic strategies. Finally, future research directions aimed at validating and incorporating emerging biomarkers into clinical practice are outlined, with the goal of improving outcomes in patients with localized prostate cancer.

The urinary and gut microbiomes are also being explored for their diagnostic and prognostic roles in PCa. In conclusion, integrating advanced molecular tools and biomarker-guided platforms into clinical practice can significantly enhance early detection, personalized treatment, and monitoring in prostate cancer, paving the way for precision oncology.

Commercially-available, noninvasive biomarker tests consistently outperformed PSA and PSA-based risk calculators for detection of csPCa. Clinical use of these tests appears to substantially reduce the proportion of unnecessary biopsies performed, while maintaining detection of the vast majority of significant cancers.