Research Activities, May 2013

PCA3 test may be more accurate at predicting prostate cancer than tPSA in men identified as at-risk

Comparative Effectiveness Research

A new research review from AHRQ finds that in men at risk for prostate cancer, there is low strength of evidence that the prostate cancer antigen 3 gene test (PCA3) has better diagnostic accuracy at predicting prostate cancer than using elevated serum total prostate specific antigen (tPSA) levels in men at risk for prostate cancer. However, there is insufficient evidence to conclude that this leads to improved intermediate or long-term health outcomes. PCA3 also appears to have better diagnostic accuracy than tPSA as a secondary test for men with increased risk. 

Prostate cancer screening has been under discussion in recent years, with the U.S. Preventive Services Task Force concluding that the potential benefits of tPSA screening do not outweigh the harms.

The U.S. Food and Drug Administration recently approved a new PCA3 assay, the first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy. When used in conjunction with other diagnostic information, the PCA3 test is intended to better inform decisionmaking about repeat biopsy. AHRQ’s review finds that more research is needed on PCA3 to assess its effectiveness in predicting prostate cancer at biopsy and to better inform biopsy, management, and treatment decisions. 

These findings and others can be found in the research review, PCA3 Testing for the Diagnosis and Management of Prostate Cancer at

Page last reviewed May 2013
Page originally created May 2013
Internet Citation: PCA3 test may be more accurate at predicting prostate cancer than tPSA in men identified as at-risk. Content last reviewed May 2013. Agency for Healthcare Research and Quality, Rockville, MD.