Prostate cancer (Pca) is a common male-specific cancer with diverse genetics and disease phenotypes. Current risk stratification tools for Pca rely on standard clinico-pathological variables like serum Prostate Specific Antigen (PSA) levels, histopathological Gleason scoring, and image-based tumor staging. PSA levels are criticized for reduced specificity, leading to over-diagnosis. Monitoring tumor progression with standard clinico-pathological parameters is challenging. Pca-specific biomarker research has primarily focused on disease diagnosis, but there is a need for novel prognostic and predictive response to treatment biomarkers. Personalized approaches for early detection, risk stratification, and treatment response prediction are essential. Recent advancements in tissue-based molecular biomarker assays through genomics and proteomics technology have created opportunities for improving diagnosis, prognosis, and management of Pca. However, these assays also pose challenges in incorporating them into routine clinical practice. This review discusses the current role of commercially and non-commercially available tissue-based molecular assays approved by FDA or Clinical Laboratory Improvement Amendments (CLIA) in local and advanced diseases and their challenges.
Keywords: Prostate cancer; PSA; Gleason score; Risk stratification; Tissue-based biomarkers; Molecular assays; Genomics; Proteomics; Diagnostic biomarkers; Prognostic biomarkers; Predictive biomarkers; CLIA-approved assays; FDA-approved assays; Personalized medicine.
How to cite this article: Sickandar F, Rajan P, Current & Emerging Role of Tissue-Based Molecular Biomarkers in Prostate Cancer. Int J Drug Deliv Technol. 2026;16(4s): 482-501; DOI: 10.25258/ijddt.16.4s.60