PCA3 - Prostate Cancer Biomarker

  • Aids in decision to repeat biopsy in men ≥50 years who have had one or more negative prostate biopsies and for whom a repeat biopsy would be recommended by a urologist based on current standard of care
  • Not for initial prostate cancer screening
  • Specimen collection must follow DRE
  • Sufficient number of prostate cells must be present in urine for analysis
  • PCA3 testing should not be used in patients with atypical small acinar proliferation (ASAP) on their most recent biopsy
Related Tests
  • Preferred initial screening test for prostate cancer in conjunction with DRE
  • Use to monitor patients for recurrence of cancer
  • Percentage of free PSA compared to total PSA
  • Not for initial prostate cancer screening
  • May provide additional prostate cancer risk information for patients with mildly elevated total PSA and a negative DRE
  • Alternative to PCA3 testing in indeterminate PSA cases

Prostate cancer is the most frequent malignant neoplasm in men and the second most common cause of cancer-related deaths in American men.  PCA3 testing may be useful in conjunction with other patient information to determine whether a biopsy should be repeated in men ≥50 years. 

Disease Overview

Physiology

PCA3 is noncoding RNA and is overexpressed in men with prostate cancer.  PCA3 has been reported to have a median 66-fold upregulation compared with adjacent nonneoplastic tissue. 

Diagnostic Issues

PCA3 testing can be helpful in determining whether to perform a repeat biopsy in patients with indeterminate PSA results. 

Test Interpretation

Clinical sensitivity: 77.5% relative to prostate biopsy outcome; based on a PCA3 ratio cutoff value of 25

Clinical specificity: 57.1% relative to prostate biopsy outcome; based on a PCA3 ratio cutoff value of 25

Results

Result PCA3 Ratio Interpretation

Negative

0-17

Associated with decreased likelihood of a positive biopsy for prostate cancer

18-24

Should be interpreted with caution; due to normal test variability, specimens with PCA3 scores near the cutoff may yield a different overall interpretation upon repeat testing

Positive

25-31

Should be interpreted with caution; due to normal test variability, specimens with PCA3 scores near the cutoff may yield a different overall interpretation upon repeat testing

>31

Associated with increased probability of a positive biopsy for prostate cancer