Early Detection Research Network

Prostate

TMPRSS2:ERG urine assay for prostate cancer detection is in studies in CLIA lab and is undergoing phase 3 validation.
http://edrn.jpl.nasa.gov/bmdb/biomarkers/organs/543/462
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The combined measurement of PCA3 and TMPRSS2:ERG in urine outperformed serum PSA for prostate cancer diagnosis. The detection of TMPRSS2:ERG fusion in urine has greater than 90% specificity and 94% positive predictive value for prostate cancer detection. Increased TMPRSS2:ERG transcript expression can be a predictor of prostate cancer. A multiplexed model including seven biomarkers (AMACR, ERG, GOLPH2, PCA3, SPINK1, TFF3, TMPRSS2:ERG) outperforms serum PSA or PCA3 alone.
8591e8b29d1543d691241e7a3f33de65
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Contents
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.

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.

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.