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Clinical Chemistry 54: 2007-2017, 2008. First published October 23, 2008; 10.1373/clinchem.2008.108845
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(Clinical Chemistry. 2008;54:2007-2017.)
© 2008 American Association for Clinical Chemistry, Inc.

Cancer Diagnostics

Performance of a Single Assay for Both Type III and Type VI TMPRSS2:ERG Fusions in Noninvasive Prediction of Prostate Biopsy Outcome

Jarrod P. Clark1, Kristofer W. Munson1,3, Jessie W. Gu2, Katarzyna Lamparska-Kupsik1, Kevin G. Chan3, Jeffrey S. Yoshida3, Mark H. Kawachi3, Laura E. Crocitto3, Timothy G. Wilson3, Ziding Feng2 and Steven S. Smith1,3,a

1 Kaplan Clinical Research Laboratory, City of Hope, Duarte, CA; 2 Biostatistics Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA; 3 Department of Urology and Urologic Oncology, City of Hope, Duarte, CA.

aAddress correspondence to this author at: Kaplan Clinical Research Laboratory, City of Hope, 1500 E. Duarte Rd., Duarte, CA 91010-3000. E-mail ssmith{at}coh.org

Background: TMPRSS2:ERG fusions are promising prostate cancer biomarkers. Because they can occur in multiple forms in a single cancer specimen, we developed a quantitative PCR test that detects both type III and type VI TMPRSS2:ERG fusions. The assay is quantified from a standard curve determined with a plasmid-cloned type III TMPRSS2:ERG fusion target.

Methods: We collected expressed prostatic secretion (EPS) under an institutional review board-approved, blinded, prospective study from 74 patients undergoing transrectal ultrasound-guided biopsy for prostate cancer. We compared the characteristic performance of the test for type III and type VI TMPRSS2:ERG fusions in predicting biopsy outcome and distinguishing between high and low Gleason scores with similar tests for the expression of PCA3 and DNA methylation levels of the APC, RARB, RASSF1, and GSTP1 genes. We used logistic regression to analyze the effects of multiple biomarkers in linear combinations.

Results: Each test provided a significant improvement in characteristic performance over baseline digital rectal examination (DRE) plus serum prostate-specific antigen (PSA); however, the test for type III and type VI TMPRSS2:ERG fusions yielded the best performance in predicting biopsy outcome [area under the curve (AUC) 0.823, 95% CI 0.728–0.919, P < 0.001] and Gleason grade >7 (AUC 0.844, 95% CI 0.740–0.948, P < 0.001).

Conclusions: Although each test appears to have diagnostic value, PSA plus DRE plus type III and type VI TMPRSS2:ERG provided the best diagnostic performance in EPS specimens.






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