TEST:

SelectMDx

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.

Prostate cancer biomarkers improve risk stratification and may lower healthcare costs. However, variations in cost-effectiveness, reimbursement policies, and guideline recommendations limit widespread adoption. Prospective studies are needed to validate real-world cost savings and refine biomarker integration into clinical practice. Addressing financial and policy challenges is essential to ensure equitable access and maximize their impact on prostate cancer management.

By assessing genetic mutations (e.g. BRCA1, BRCA2 genes, single nucleotide polymorphism) or the presence of splice variants of the androgen receptor (ARV7), we are able to identify patients in whom the planned treatment may be expected to be ineffective and thus choose other treatment modalities. In the present review article, we offer a comprehensive overview of current diagnostic tests that find application in the diagnosis of early and advanced prostate cancer.

Additionally, the review explores the role of tumor-associated microbiota in PCa, offering new insights into its potential contributions to disease understanding. By examining the latest advancements in PCa biomarkers, this review enhances understanding their roles in disease management.

Long-term clinical PrCa outcomes will be collected annually until the study closes. (clinicaltrials.gov: NCT04472338.

The contemporary literature further supports the proposed role of post-PSA biomarker testing to reduce the use of invasive biopsy while maintaining highly sensitive detection of GG ≥ 2 cancer. Questions remain regarding the optimal application of biomarkers in combination or in sequence with mpMRI.