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Development and clinical validation of a real-time PCR assay for PITX2 DNA methylation to predict prostate-specific antigen recurrence in prostate cancer patients following radical prostatectomy.

Publication ,  Journal Article
Dietrich, D; Hasinger, O; Bañez, LL; Sun, L; van Leenders, GJ; Wheeler, TM; Bangma, CH; Wernert, N; Perner, S; Freedland, SJ; Corman, JM ...
Published in: J Mol Diagn
March 2013

Prostate cancer is the most common cancer among men. The prospective discrimination of aggressive and clinically insignificant tumors still poses a significant and, as yet, unsolved problem. PITX2 DNA methylation is a strong prognostic biomarker in prostate cancer. Recently, a diagnostic microarray for prostate cancer prognosis based on PITX2 methylation has been developed and validated. Because this microarray requires nonstandard laboratory equipment, its use in a diagnostic setting is limited. This study aimed to develop and validate an alternative quantitative real-time PCR assay for measuring PITX2 methylation that can easily be established in clinical laboratories, thereby facilitating the implementation of this biomarker in clinical practice. A methylation cut-off for patient stratification was established in a training cohort (n = 157) and validated in an independent test set (n = 523) of men treated with radical prostatectomy. In univariate Cox proportional hazards analysis, PITX2 hypermethylation was a significant predictor for biochemical recurrence (P < 0.001, hazard ratio = 2.614). Moreover, PITX2 hypermethylation added significant prognostic information (P = 0.003, hazard ratio = 1.814) to the Gleason score, pathological T stage, prostate-specific antigen, and surgical margins in a multivariate analysis. The clinical performance was particularly high in patients at intermediate risk (Gleason score of 7) and in samples containing high tumor cell content. This assay might aid in risk stratification and support the decision-making process when determining whether a patient might benefit from adjuvant treatment after radical prostatectomy.

Duke Scholars

Published In

J Mol Diagn

DOI

EISSN

1943-7811

Publication Date

March 2013

Volume

15

Issue

2

Start / End Page

270 / 279

Location

United States

Related Subject Headings

  • Transcription Factors
  • Reproducibility of Results
  • Recurrence
  • Real-Time Polymerase Chain Reaction
  • Prostatic Neoplasms
  • Prostatectomy
  • Prostate-Specific Antigen
  • Prognosis
  • Pathology
  • Neoplasm Staging
 

Citation

APA
Chicago
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MLA
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Dietrich, D., Hasinger, O., Bañez, L. L., Sun, L., van Leenders, G. J., Wheeler, T. M., … Kristiansen, G. (2013). Development and clinical validation of a real-time PCR assay for PITX2 DNA methylation to predict prostate-specific antigen recurrence in prostate cancer patients following radical prostatectomy. J Mol Diagn, 15(2), 270–279. https://doi.org/10.1016/j.jmoldx.2012.11.002
Dietrich, Dimo, Oliver Hasinger, Lionel L. Bañez, Leon Sun, Geert J. van Leenders, Thomas M. Wheeler, Chris H. Bangma, et al. “Development and clinical validation of a real-time PCR assay for PITX2 DNA methylation to predict prostate-specific antigen recurrence in prostate cancer patients following radical prostatectomy.J Mol Diagn 15, no. 2 (March 2013): 270–79. https://doi.org/10.1016/j.jmoldx.2012.11.002.
Dietrich D, Hasinger O, Bañez LL, Sun L, van Leenders GJ, Wheeler TM, Bangma CH, Wernert N, Perner S, Freedland SJ, Corman JM, Ittmann MM, Lark AL, Madden JF, Hartmann A, Schatz P, Kristiansen G. Development and clinical validation of a real-time PCR assay for PITX2 DNA methylation to predict prostate-specific antigen recurrence in prostate cancer patients following radical prostatectomy. J Mol Diagn. 2013 Mar;15(2):270–279.
Journal cover image

Published In

J Mol Diagn

DOI

EISSN

1943-7811

Publication Date

March 2013

Volume

15

Issue

2

Start / End Page

270 / 279

Location

United States

Related Subject Headings

  • Transcription Factors
  • Reproducibility of Results
  • Recurrence
  • Real-Time Polymerase Chain Reaction
  • Prostatic Neoplasms
  • Prostatectomy
  • Prostate-Specific Antigen
  • Prognosis
  • Pathology
  • Neoplasm Staging