The PCA3 test may be useful, in conjunction with other patient information, to aid in the decision for repeat biopsy in men 50 years of age or older 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.
This test should not be used for men with a result of Atypical Small Acinar Proliferation (ASAP) on their most recent biopsy. Performance has not been established in men who undergo a repeat biopsy less than 3 months or more than 7 years after their most recent negative biopsy. The effect of medications known to influence serum PSA levels or therapeutic and/or diagnostic procedures such as prostatectomy, radiation, or prostate biopsy that may impact the viability of prostatic tissue and PCA3 Score have not been evaluated.
Collection must follow digital rectal exam (DRE)
Collect 20-30 mL first catch urine following DRE in preservative-free urine collection cup
Frozen (preferred) – 3 months
Refrigerated – 5 days
Ambient – 5 days
Qualitative Transcription-Mediated Amplification (TMA)
Negative (0 - 17 ratio)
PCA3 ratio |
Interpretation |
0-17 |
Negative - Result associated with decreased likelihood of a positive biopsy for prostate cancer. |
18-24 |
Negative - Result should be interpreted with caution. Due to normal test variability, specimens with PCA3 scores near the cut-off may yield a different overall interpretation upon repeat testing. |
25-31 |
Positive - Result should be interpreted with caution. Due to normal test variability, specimens with PCA3 scores near the cut-off may yield a different overall interpretation upon repeat testing. |
>31 |
Positive - Result associated with increased probability of a positive biopsy for prostate cancer. |