PCA3 urine mRNA testing for prostate carcinoma: patterns of use by community urologists and assay performance in reference laboratory setting.

Objectives: Multiple trials have shown the high specificity of urine prostate cancer gene 3 (PCA3) compared with serum prostate-specific antigen (PSA) for biopsy detection of prostate carcinoma. We characterized the patterns of use of PCA3 by community urologists and determined the performance of PCA3 testing as a laboratory-developed test in a reference laboratory setting.

Methods: The urine PCA3 and PSA mRNA levels after digital rectal examination were determined using transcription-mediated amplification.