Research In Brief
This article was originally published in The Gray Sheet
Executive Summary
PCA3 test for prostate cancer: Data presented June 1 at the American Urological Association annual meeting shows Gen-Probe's Progensa urine-based molecular test is significantly more specific than prostate specific antigen in detecting prostate cancer. A multi-practice, community-urologist-based clinical trial evaluated PCA3 in 1,994 urine samples from men with elevated serum PSA and/or an abnormal digital rectal exam, of which 1,946 had enough prostatic cells for PCA3 testing. Researchers found that 816 patients (42%) had prostate cancer, and another 219 (11%) had high-grade prostatic intraepithelial neoplasia and/or atypical small acinar proliferation suspicious for cancer. The results concluded PCA3 has an odds ratio of 3.4 for predicting prostate cancer versus 1.7 for PSA. PCA3 had a specificity of 78% and sensitivity of 49%, versus 21% and 87%, respectively, for PSA. The PCA3 gene is overexpressed in more than 90% of prostate cancers. The assay has CE-mark approval in Europe; Gen-Probe initiated a U.S. clinical trial in August 2009 and plans to submit a PMA application later this year