Prostate cancer antigen 3 (PCA3, also referred to as DD3) is a gene that expresses a non-coding RNA. PCA3 is only expressed in human prostate tissue, and the gene is highly overexpressed in prostate cancer Because of its restricted expression profile, the PCA3 RNA is being studies as a tumor marker for prostate cancer.

The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group found insufficient evidence to recommend prostate cancer antigen 3 (PCA3) testing to inform decisions for when to rebiopsy previously biopsy-negative patients for prostate cancer or to inform decisions to conduct initial biopsies for prostate cancer in at-risk men (e.g., previous elevated prostate-specific antigen test or suspicious digital rectal examination).

The EGAPP Working Group found insufficient evidence to recommend PCA3 testing in men with cancer-positive biopsies to determine if the disease is indolent or aggressive in order to develop an optimal treatment plan.

Based on the available evidence, the overall certainty of clinical validity to predict the diagnosis of prostate cancer using PCA3 is deemed “low.” The EGAPP Working Group discourages clinical use for diagnosis unless further evidence supports improved clinical validity.

Based on the available evidence, the overall certainty of net health benefit is deemed “low.” The EGAPP Working Group discourages clinical use unless further evidence supports improved clinical outcomes.

Recommendations from the EGAPP Working Group: does PCA3 testing for the diagnosis and management of prostate cancer improve patient health outcomes? Genetics in Medicine (2014)16, 338–346

Schilling D, Hennenlotter J, Munz M, et al. (2010). “Interpretation of the prostate cancer gene 3 in reference to the individual clinical background: implications for daily practice.”. Urol. Int. 85 (2): 159–65.

Day JR, Jost M, Reynolds MA, et al. (2011). “PCA3: from basic molecular science to the clinical lab.”. Cancer Lett. 301 (1): 1–6