Publication
Ochiai A, Okihara K, Kamoi K, Iwata T, Kawauchi A, Miki T, Fors Z. Int J Urol 2011;18:200-5
- This study confirms that the PCA3 Assay can be used to guide prostate biopsy decisions in Japanese men
- This single-centre study included 105 consecutive men with a serum PSA ≥ 2.5 ng/mL and/or an abnormal digital rectal examination (DRE) who underwent an extended (≥ 8 cores) prostate biopsy. 85 men had an initial biopsy and 20 a repeat biopsy
- The informative rate of the PROGENSA® Assay was 100% showing that the test is robust and ensures low patient recall (informative rate: percentage of urine samples containing sufficient PCA3 mRNA for calculation of the PCA3 Score)
- The positive biopsy rate was 36%
- The median PCA3 Score was statistically significantly higher in men with a positive (59.5) compared to men with a negative biopsy (14.2; P<0.0001; Figure)
- The PCA3 Score was independent of age, serum PSA level and prostate volume
- The diagnostic accuracy of the PCA3 Score for predicting biopsy outcome was statistically significantly better than that for serum PSA in men with a serum PSA 2.5-50 ng/mL and a serum PSA 4-10 ng/mL (Table)
- In multivariate analysis, the PCA3 Score was a significant independent predictor of biopsy outcome in men with a serum PSA 4-10 ng/mL
- At a PSA 4-10 ng/mL at a fixed sensitivity of 88%, the specificity of the PCA3 Score (cut-off 20) was 62% while the specificity of PSA (cut-off 4.6 ng/mL) was 21% and of PSAD (cut-off 0.16) was 47%
- It was concluded that the PCA3 Score could improve the prediction of prostate cancer and help to better select men who might benefit from a prostate biopsy. This is not only the case for European and American men, but also for Asian men
Figure: The median PCA3 Score is statistically significantly higher in men with a positive first or repeat biopsy than in men with a negative biopsy

| AUC ROC | PCA3 Score | PSA | P-value |
| Men with PSA 2.5-50 ng/mL (n=102) | 0.8507 | 0.7243 | 0.0254 |
| Men with PSA 4-10 ng/mL (n=70) | 0.8230 | 0.5888 | 0.0008 |
More information: Article at PubMed
