Clinical Information

Background: PCA3 is a non-coding prostate-specific mRNA that is highly over-expressed in some prostate cancer cells (median 66-fold over adjacent benign tissue); in contrast. PSA gene expression is similar in benign and malignant prostate cells. Both PCA3 and PSA mRNA can be quantitated from urine samples. The PCA3 assay utilizes voided urine collected following a digital rectal examination and processed by addition into a urine transport medium (UTM) which lyses cells and stabilizes RNA. The PSA mRNA level serves to confirm that there is sufficient prostate RNA for analysis present in the sample and to normalize the PCA3 mRNA signal. In a study of 466 patients with previous negative prostate biopsy, 102 of whom had a positive follow-up biopsy, utilizing the PCA3 score cutoff value of 25 was shown to have 77.5% sensitivity and 57.1% specificity for prostate cancer. This assay is indicated for use in conjunction with other patient information to aid in the decision of repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended by a urologist based on current standard of care, before consideration of the PCA3 assay results. This assay should not be used for men with atypical small acinar proliferation (ASAP) on their most recent biopsy; men with ASAP on their most recent biopsy should be treated in accordance with current medical guidelines.

This figure shows the percentage of subjects with positive biopsy results by PCA3 score interval.