ABSTRACT
Many candidate biomarkers for diagnosis of prostate cancer have been investigated; but prostate-specific antigen (PSA) testing remains the frontline test for both mass screening and individual clinical testing. Although the PSA test is cost-effective; analytically reliable; and flexibly high throughput; it has a very weak correlation with prostate malignancy. This has resulted in over-diagnosis and over-treatment of patients leading to costly economic; social; and psychological impacts. PSA testing lacks the ability to molecularly characterize prostate diseases and define aggressiveness and lethality; which are necessary to influence choice of treatment. Therefore; newer molecular tests are beginning to replace the PSA tests. The prostate cancer antigen 3 test has shown superiority and is now widely used. The recently reported sarcosine urine test; the already delineated TMPRSS2: ETS fusion genes; the glutathione-S-transferase P1 serum marker; and enhancer of zeste homolog 2 biomarker may also help improve diagnosis and prognostication of prostate cancer. The analytical trend is toward a multiplex testing format using molecular and/or proteomic techniques that are reliable; accurate; reproducible; and ensure rapid quantitation. Therefore; validation of these newer biomarkers and their assays are necessary for both large-scale clinical trials and clinical utility