Abstract
BackgroundProstate cancer (PCa) is the most common male cancer in Europe and the US. The early diagnosis relies on prostate specific antigen (PSA) serum test, even if it showed clear limits. Among the new tests currently under study, one of the most promising is the prostate cancer gene 3 (PCA3), a non-coding mRNA whose level increases up to 100 times in PCa tissues when compared to normal tissues. With the present study we contribute to the validation of the clinical utility of the PCA3 test and to the evaluation of its prognostic potential.Methods407 Italian men, with two or more PCa risk factors and at least a previous negative biopsy, entering the Urology Unit of Regina Elena National Cancer Institute, were tested for PCA3, total PSA (tPSA) and free PSA (fPSA and f/tPSA) tests. Out of the 407 men enrolled, 195 were positive for PCa and 114 of them received an accurate staging with evaluation of the Gleason score (Gs). Then, the PCA3 score was correlated to biopsy outcome, and the diagnostic and prognostic utility were evaluated.ResultsOut of the 407 biopsies performed after the PCA3 test, 195 (48%) resulted positive for PCa; the PCA3 score was significantly higher in this population (p < 0.0001) differently to tPSA (p = 0.87). Moreover, the PCA3 test outperformed the f/tPSA (p = 0.01). The sensitivity (94.9) and specificity (60.1) of the PCA3 test showed a better balance for a threshold of 35 when compared to 20, even if the best result was achieved considering a cutoff of 51, with sensitivity and specificity of 82.1% and 79.3%, respectively. Finally, comparing values of the PCA3 test between two subgroups with increasing Gs (Gs ≤ 6 versus Gs ≥ 7) a significant association between PCA3 score and Gs was found (p = 0.02).ConclusionsThe PCA3 test showed the best diagnostic performance when compared to tPSA and f/tPSA, facilitating the selection of high-risk patients that may benefit from the execution of a saturation prostatic biopsy. Moreover, the PCA3 test showed a prognostic value, as higher PCA3 score values are associated to a greater tumor aggressiveness.
Highlights
Prostate cancer (PCa) is the most common male cancer in Europe and the US
The probability to find a positive biopsy strongly correlates with the prostate cancer gene 3 (PCA3) test, as the probability to find a PCa-positive biopsy is higher at increased PCA3 score values (p < 0.0001)
For our cohort, the median total PSA (tPSA) value was similar between the two subgroups (p = 0.87), while a significant difference was found for the Free prostate specific antigen (PSA) (fPSA)/tPSA ratio (f/tPSA) (p = 0.01); the best result was obtained considering the different distribution of the PCA3 score (p < 0.0001) between PCa and nonPCa patients
Summary
Prostate cancer (PCa) is the most common male cancer in Europe and the US. The early diagnosis relies on prostate specific antigen (PSA) serum test, even if it showed clear limits. Among the new tests currently under study, one of the most promising is the prostate cancer gene 3 (PCA3), a non-coding mRNA whose level increases up to 100 times in PCa tissues when compared to normal tissues. The PSA test brought to the diagnosis of a high number of asymptomatic and preclinical forms of PCa, but it has not been associated with a decrease in mortality, opening a wide debate on the diagnostic utility of this test [6]. We report the results of the PCA3 test among an Italian prospective cohort of high-risk PCa patients in order to evaluate its actual clinical utility as a diagnostic test additional and/or alternative to the PSA test. The correlation between the results of the PCA3 test and the tumor aggressiveness has been evaluated
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