Early Detection Research Network


The prostate cancer antigen 3 (PCA3) gene is a highly specific biomarker upregulated in prostate cancer. The PCA3 gene (prostate cancer antigen 3) is a non-coding gene that is over-expressed in prostate cancer. PCA3 in conjunction with other clinical tools has been shown to be as effective as the PSA (prostate specific antigen) assay in predicting the presence of prostate cancer. The FDA recently approved the first molecular test that uses PCA3 to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy.
The FDA has approved an assay for prostate cancer that uses the ratio of PCA3 RNA to PSA RNA in urine. The assay is used to help physicians determine the need for repeat prostate biopsies in men 50 years of age or older who have had a previous negative biopsy. When used in conjunction with other clinical information, the use of this test can reduce the need for unnecessary prostate biopsies.
Prostate Active Surveillance Study

Primary Objective: To discover and confirm biomarkers that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables. Secondary Objectives: To determine the proportion of patients on active surveillance who progress based on the above criteria. To determine the clinical predictors of disease progression. To measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer.

PASS Reference Set Application: Lin UW (2010) TMPRSS2-ERG-PCA-PASS

Active surveillance is used to manage low-risk prostate cancer. Both PCA3 and TMPRSS2:ERG are promising biomarkers that may be associated with aggressive disease. This study examines the correlation of these biomarkers with higher cancer volume and grade determined at the time of biopsy in an active surveillance cohort.

PCA3 Reference Set Application: T2-Erg-Martin Sanda-Emory (2014)

We hypothesize that combining T2:erg (T2:erg) fusion and PCA3 detection in urine collected after digital rectal exam can improve the specificity of identifying clinically significant prostate cancer presence over the standard PSA and DRE. To address this hypothesis we propose to validate the performance of the urinary T2:erg in a multiplex model predicting the diagnosis of clinically significant prostate cancer on subsequent prostate biopsy using post-DRE pre biopsy urine specimens from a cohort of 900 men on the EDRN’s PCA3 trial.