Abstract
BackgroundAdditional accurate non-invasive biomarkers are needed in the clinical setting to improve prostate cancer (PCa) diagnosis. Here we have developed a new and improved multiplex mRNA urine test to detect prostate cancer (PCa). Furthermore, we have validated the PCA3 urinary transcript and some panels of urinary transcripts previously reported as useful diagnostic biomarkers for PCa in our cohort.MethodsPost-prostatic massage urine samples were prospectively collected from PCa patients and controls. Expression levels of 42 target genes selected from our previous studies and from the literature were studied in 224 post-prostatic massage urine sediments by quantitative PCR. Univariate logistic regression was used to identify individual PCa predictors. A variable selection method was used to develop a multiplex biomarker model. Discrimination was measured by ROC curve AUC for both, our model and the previously published biomarkers.ResultsSeven of the 42 genes evaluated (PCA3, ELF3, HIST1H2BG, MYO6, GALNT3, PHF12 and GDF15) were found to be independent predictors for discriminating patients with PCa from controls. We developed a four-gene expression signature (HIST1H2BG, SPP1, ELF3 and PCA3) with a sensitivity of 77 % and a specificity of 67 % (AUC = 0.763) for discriminating between tumor and control urines. The accuracy of PCA3 and previously reported panels of biomarkers is roughly maintained in our cohort.ConclusionsOur four-gene expression signature outperforms PCA3 as well as previously reported panels of biomarkers to predict PCa risk. This study suggests that a urinary biomarker panel could improve PCa detection. However, the accuracy of the panels of urinary transcripts developed to date, including our signature, is not high enough to warrant using them routinely in a clinical setting.Electronic supplementary materialThe online version of this article (doi:10.1186/s12885-016-2127-2) contains supplementary material, which is available to authorized users.
Highlights
Additional accurate non-invasive biomarkers are needed in the clinical setting to improve prostate cancer (PCa) diagnosis
The routine use of prostate-specific antigen (PSA) has been the subject of continued controversy owing to its limited specificity, which derives from the fact that elevated serum levels of PSA occur in a variety of non-neoplastic conditions such as prostatitis and benign prostate hyperplasia (BPH) [1]
We have previously identified new putative mRNA markers for PCa diagnosis that can be extrapolated to post-prostatic massage (PPM) urine samples [13]
Summary
Additional accurate non-invasive biomarkers are needed in the clinical setting to improve prostate cancer (PCa) diagnosis. We have developed a new and improved multiplex mRNA urine test to detect prostate cancer (PCa). During the last two decades, prostate-specific antigen (PSA) has been extensively used for prostate cancer (PCa) screening, detection and follow-up. The current gold standard method for diagnosis of PCa in patients with elevated serum PSA is non-targeted transrectal ultrasound-guided needle biopsy, which fails to detect PCa in approximately 20–30 % of cases [3]. There is a need for additional non-invasive and more specific markers of early PCa that will permit the stratification of patients according to their risk of developing PCa and identify men who will require prostate biopsy. Taking into account the heterogeneity of PCa, several authors have searched for a multiplex detection system of biomarkers, which has proved to outperform the diagnostic value of the individual markers [9,10,11,12]
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