Publication
Tosoian JJ, Loeb S, Kettermann A, Landis P, Elliot DJ, Epstein JI, Partin AW, Ballentine Carter H, Sokoll LJ. J Urol 2010;183:534-8
- This observational cohort study showed that in men with low-risk prostate cancer (PCa) selected for active surveillance the PCA3 Score there was a trend towards higher PCA3 scores in patients with progression on biopsy; however, this did not reach statistical significance
- A total of 294 men with low-risk PCa (T1c, PSA density < 0.15 ng/mL/cm3, Gleason score < 7, ≤ 2 positive biopsy cores, ≤ 50% of any core containing PCa) were included in the Johns Hopkins active surveillance program and followed with a.o. an annual (12-core) biopsy. The first PCA3 Score assessed at start of the study (early 2007) was used for the analysis
- A total of 38 patients (12.9%) had progression on biopsy (i.e. Gleason pattern 4 or 5, > 2 positive cores or > 50% involvement of any core with cancer)
- The mean PCA3 Score at the start of the study tended to be higher in men with progression on biopsy vs. those without; however this was not statistically significant (60.0 vs. 50.8 (median 46.7 vs. 33.0) (P=0.131); Figure)
- More men with progression on biopsy had a PCA3 Score ≥ 25 or 35 than men without progression. Likewise, more men without progression had a PCA3 Score < 25 or 35 than men with progression (Figure)
- In 16 patients with progression and a Gleason score ≥ 7, the mean PCA3 Score was 72 (median 58.7) compared to 51.2 (median 40.3) in 22 patients with progression and a Gleason score < 7 (P=0.174)
- Receiver operating characteristic (ROC) analysis suggested that the PCA3 Score alone could not be used to predict progression on biopsy (Area Under the Curve (AUC): 0.589, 95% confidence interval (CI) 0.496-0.683; P=0.076)
- The high informative rate of 97.7% confirms that the PROGENSA® PCA3 test is very robust
- It was commented that this study was limited in that there was only a relatively short follow-up period for progression to occur and that it is unknown whether patients with progression on biopsy truly had progression or that this instead represents previously under-sampled disease. In addition, the performance characteristics of PCA3 may be different when longitudinal PCA3 Scores during the follow-up would have been used instead of a single initial PCA3 Score. A sample-size calculation was also not performed. Furthermore, this study included patients with low-risk PCa and the outcome may be different in other populations and with other definitions of progression
- It was concluded that in men with low-risk PCa selected for active surveillance the PCA3 Score was not significantly associated with progression on biopsy in the short term. There was a trend toward higher PCA3 Scores in patients with progression on biopsy and particularly in those men with Gleason grade progression. Further studies (with longer follow-up) are needed to assess the usefulness of PCA3 in predicting progression, in combination with other biomarkers or in selected subsets of patients
More information: Article at PubMed