The PCA3 test, which measures PCA3 mRNA in urine samples after DRE and was approved by the FDA in 2012 as a risk assessment tool for prostate cancer, has been demonstrated as a useful tool to aid in guiding biopsy decision among men with prior negative prostate biopsies and improve the early PCa detection rate [12–14]. This evidence concerns the gene PCA3 and prostate carcinoma.