DD3(PCA3)-based molecular urine analysis for the diagnosis of prostate cancer

Eur Urol. 2003 Jul;44(1):8-15; discussion 15-6. doi: 10.1016/s0302-2838(03)00201-x.


Background: DD3(PCA3) is the most prostate cancer-specific gene described to date. To assess the clinical utility of DD3(PCA3) a time-resolved fluorescence-based, quantitative RT-PCR analysis for DD3(PCA3) was developed.

Methods: The diagnostic potential of DD3(PCA3) was determined by quantitative measurement of DD3(PCA3) transcripts in non-malignant and malignant prostate specimens. Moreover, DD3(PCA3) transcripts were determined quantitatively in urine sediments obtained after prostatic massage. A cohort of 108 men, admitted for prostate biopsies based on a PSA of >3ng/ml, was studied.

Results: Prostate tumors showed a 66-fold up-regulation of DD3(PCA3) (median 158.4.10(5) copies/microg tissue RNA) when compared to benign prostate tissue (median 2.4.10(5) copies/microg tissue RNA). This up-regulation was found in more than 95% of prostate cancer specimens studied. These data revealed that specimens with less than 10% of cancer cells could be accurately discriminated from non-cancer tissues. Hence, detection of a small fraction of prostate cancer cells in a background of normal cells seemed feasible. Therefore, this DD3(PCA3)-based RT-PCR assay was used for the identification of prostate cancer in urine sediments obtained after prostatic massage. From 108 men with a serum PSA value >3ng/ml, 24 men were shown to have prostate cancer upon biopsy. Of these 24 men, 16 were shown to be positive for DD3(PCA3), indicating a sensitivity of the assay of 67%. Furthermore, a negative predictive value of 90% was calculated.

Conclusion: The quantitative RT-PCR assay for DD3(PCA3) described, bears great promise as a tool for molecular urine analysis. It has great potential in reducing the number of unnecessary biopsies. A multi-center study using this DD3(PCA3) assay can provide the basis for the utility of molecular diagnostics in clinical urological practice.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Base Sequence
  • Biopsy, Needle
  • Case-Control Studies
  • Cohort Studies
  • Gene Expression Regulation, Neoplastic*
  • Genetic Predisposition to Disease*
  • Humans
  • Male
  • Middle Aged
  • Molecular Sequence Data
  • Predictive Value of Tests
  • Prognosis
  • Prostate-Specific Antigen / genetics*
  • Prostate-Specific Antigen / urine
  • Prostatectomy / methods
  • Prostatic Neoplasms / genetics*
  • Prostatic Neoplasms / pathology
  • Prostatic Neoplasms / surgery
  • RNA, Neoplasm / analysis
  • ROC Curve
  • Reference Values
  • Reverse Transcriptase Polymerase Chain Reaction*
  • Sensitivity and Specificity


  • RNA, Neoplasm
  • Prostate-Specific Antigen