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Aim: To evaluate the performance of urinary PCA3 test to predict prostate biopsy outcome in a large French cohort., Patients and Methods: A urine sample was prospectively obtained in 1015 patients undergoing prostate biopsies to determine the PCA3 score. The predictive value of PCA3 was explored using receiver operating characteristic curve analysis (ROC), multivariable logistic regression analysis and decision curve analysis., Results: The median PCA3 score was significantly higher in patients with positive biopsies. The PCA3 score AUC was 0.76 (0.73-0.79), significantly higher than that of PSA (0.55; 0.51-0.58). At the cut-off of 35, sensitivity was 68 %, specificity 71 %, positive and negative predictive values 67 % and 71 %, and accuracy 69 %. Using multivariate analysis, PCA3 score appeared as an independent predictor of biopsy outcome and its addition to a base model including usual clinico-biological parameters resulted in a significant increase in predictive accuracy. At the cut-off of 20, about 1/2 of the eventual useless biopsies would have been avoided while ignoring 7 % of cancers with Gleason score ≥ 7. PCA3 score did not correlate to Gleason score but correlated to tumor volume (proportion of invaded cores)., Conclusion: Urinary PCA3 is a useful test with high diagnostic performance for early prostate cancer diagnosis. Its correlation with cancer aggressiveness seems rather represented by a link to prostate volume than Gleason score., (Copyright © 2015 Elsevier Masson SAS. All rights reserved.)

Purpose: Similar to prostate-specific antigen (PSA) density, PCA3 density (PCA3D: ratio of urinary PCA3 score/prostate volume) can be calculated, but whether it can be an aid to decide biopsy in patients at risk of prostate cancer (PCa) is uncertain. The objective was to demonstrate that PCA3D provides better specificity than PCA3 in predicting initial prostate biopsy outcome., Methods: Serum and urine samples were obtained from 595 consecutive patients scheduled for initial prostate biopsy. The urinary PCA3 test was performed before biopsy. Additional measures were prostate volume, PSA density (PSAD) and PCA3D. Multivariate logistic regression models including baseline characteristics and the markers were evaluated. The presumed net benefit was assessed through decision curve analyses., Results: PSAD and PCA3D performed better than PSA and PCA3 score, respectively. PCA3D provided the best specificity (76 %). The best calculated cutoff for PCA3D was 1. The risk of positive biopsy significantly increased to 70 % if PCA3D ≥ 1 versus 29 % if PCA3D was <1. Using a cutoff at 0.5 for PCA3D, biopsies could have been avoided in up to 52 % of the patients without PCa while missing 15 % of any PCa and 10 % of PCa with Gleason score ≥7. Decision curve analyses showed that PSAD was the best predictor of Gleason score at biopsy while PCA3D best predicted the proportion of invaded cores., Conclusions: PCA3D showed a significant increase in specificity when compared with PSA, PSAD and PCA3. PCA3D can be considered an easy-to-use mini-nomogram with a 70 % risk of positive initial biopsy when PCA3D > 1, i.e., PCA3 score > prostate volume.

It has been suggested that urinary PCA3 and TMPRSS2:ERG fusion tests and serum PHI correlate to cancer aggressiveness-related pathological criteria at prostatectomy. To evaluate and compare their ability in predicting prostate cancer aggressiveness, PHI and urinary PCA3 and TMPRSS2:ERG (T2) scores were assessed in 154 patients who underwent radical prostatectomy for biopsy-proven prostate cancer. Univariate and multivariate analyses using logistic regression and decision curve analyses were performed. All three markers were predictors of a tumor volume≥0.5 mL. Only PHI predicted Gleason score≥7. T2 score and PHI were both independent predictors of extracapsular extension(≥pT3), while multifocality was only predicted by PCA3 score. Moreover, when compared to a base model (age, digital rectal examination, serum PSA, and Gleason sum at biopsy), the addition of both PCA3 score and PHI to the base model induced a significant increase (+12%) when predicting tumor volume>0.5 mL. PHI and urinary PCA3 and T2 scores can be considered as complementary predictors of cancer aggressiveness at prostatectomy.

Introduction: Determinate if the adjunction of PCA3 score and/or prostatic MRI can improve the selection of the patients who have an indication of first prostate biopsy., Patients and Methods: Multiparametric prostatic MRI and PCA3 score were made before biopsy to men scheduled for initial prostate biopsy for abnormal digital rectal examination and/or PSA superior to 4 ng/mL. T2-weighted imaging, diffusion-weighted imaging and dynamic contrast-enhanced imaging looked for suspect target classified on a scale of four. It was a prospective, single centre study. The diagnostic accuracy of PCA3 score and MRI was to evaluate in comparison with biopsy results., Results: Sixty-eight patients were included, median PSA was 5.2 ng/mL (3.2-28). Negative predictive value (NPV) of MRI score 0, 1 and 2 were respectively 80%, 43% and 69%. Positive predictive value (PPV) of MRI score 3 and 4 were 50% and 81%. The PCA3 cutoff with best accuracy was 21 (Se: 0.91; Sp: 0.50). Only one patient with positive biopsy (0.5mm of Gleason score 3+3) had negative MRI and PCA3 inferior to 21., Conclusion: MRI and PCA3 score in association allowed, in this study, to consider reduction of unnecessary initial biopsy without ignoring potential aggressive tumor., (Copyright © 2012 Elsevier Masson SAS. All rights reserved.)

Background: The influence of chronic prostatitis on serum PSA level is well known. Whether it also influences potential new biomarkers of prostate cancer (PCa) has to be determined. We conducted a prospective study to evaluate the effect of chronic prostatitis on the PCa urinary marker PCA3., Methods: Included were 38 patients, mean-aged of 37.5 years, with clinical suspicion of chronic prostatitis. A simplified version of the Meares-Stamey four-glass localization test was performed and urine specimens were collected for cytological analysis and culture. A postprostatic massage urine sample was used for the urinary PCA3 test., Results: Four patients had an eventual diagnosis of urethritis and all had a PCA3 score less than 5. Among the remaining 34 patients, 7 had bacterial chronic prostatitis (NIH II prostatitis), 11 had abacterial chronic prostatitis (NIH IIIa), and 16 had non inflammatory prostatodynia (NIH IIIb). All these patients had a PCA3 score less than 28, that is, under the cutoff of 35, which is commonly used for prostate cancer diagnosis. Patients with NIH category IIIa prostatitis had significantly higher number of leukocytes and red cells as well as prostate cells in urine samples but their PCA3 scores did not differ from those of other prostatitis patients., Conclusion: In this study, NIH II and III chronic prostatitis did not influence the PCA3 score. Our results suggest that increased PCA3 score is unlikely to be explained by the sole chronic prostatitis and warrants prostate biopsies to eliminate prostate cancer., (Copyright © 2011 Wiley Periodicals, Inc.)

Purpose: The urinary PCA3 gene test has proved helpful for deciding whether to (re)biopsy to diagnose prostate cancer. We searched for pathological features that influence the shedding of PCA3 producing prostate cancer cells in urine after digital rectal examination., Materials and Methods: Included in our study were 102 patients with an informative PCA3 score on the Progensa® PCA3 assay who underwent radical prostatectomy. Correlations were evaluated between PCA3 score and histopathological factors on prostatectomy, including tumor site in the prostate and the number of cancer foci., Results: PCA3 score significantly correlated with total tumor volume in prostatectomy specimens (p <0.001) but not with prostatectomy Gleason score or pathological stage. PCA3 score positively correlated with apical and basal invasion, and with bilaterality and multifocality. On multivariate analysis multifocality was an independent factor influencing PCA3 score (p = 0.012)., Conclusions: Site in the prostate gland and the number of cancer foci may explain the observed PCA3 score variation in patients operated on for prostate cancer. The PCA3 test could be helpful in preoperatively selecting patients with unifocal and unilateral cancer who could benefit from active surveillance or focal therapy., (Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

The poor specificity of diagnostic strategy for prostate cancer (digital rectal examination and seric PSA) induces both a great number of useless prostate biopsies and diagnosis of non evolutive cancers. A urinary test (Progensa PCA3(®), Gen-Probe) measuring the expression of PCA3, a prostate cancer-specific gene, has recently be proposed to indicate re-biopsy. The aim of this prospective study was to evaluate diagnostic value of urinary PCA3 test for prostate cancer. In the urines of 245 patients submitted to prostate biopsy, expression of the PCA3 gene was measured and reported to that of PSA to calculate PCA3 score using a method amplifying and detecting RNA. Patients with informative samples (98%) were classified depending of the presence (n = 126) or absence (n = 114) of cancer tissue on biopsies. The median PCA3 score was significantly higher in the group with positive biopsies (p < 0.0001). Area under ROC curve was 0.70 for PCA3 as compared to that of PSA (0.53) and free/total PSA ratio (0.65). At the best threshold of 38, PCA3 test had a 59%-sensitivity and a 72%-specificity, as compared to 66% and 32% for total PSA (threshold 4 ng/mL) and 81% and 28% for free/total PSA ratio (threshold 25%). These performances were maintained in patients with seric PSA within the grey zone (4-10 ng/mL) and those with previous prostate biopsies. This study confirms the clinical value of PCA3 urinary test in helping decision for biopsies in patients with suspected prostate cancer.

The prostate cancer 3 (PCA3) gene was discovered in 1999, on the basis of differential expression between cancer and noncancerous prostate tissue. Including the first study published in 2003, 11 clinical studies have evaluated its utility for the diagnosis of prostate cancer by measuring the number of PCA3 RNA copies in urine enriched with prostate cells. Although the sensitivity of the PCA3 test was less than that of serum prostate-specific antigen (PSA), its specificity appeared to be much better, particularly in patients with a previous negative biopsy. Recent studies also have suggested that this test could be used to predict cancer prognosis., (2010 Elsevier Inc. All rights reserved.)

PCA3 gene has been discovered in 1999 because of its differential expression between prostate cancer and nonneoplastic tissue. Several studies evaluated its value for prostate cancer diagnosis. These papers are consistent with significant statistical accuracy of measure of the urinary number of PCA3 copies (PCA3 test). While sensitivity is slightly weaker than that of seric PSA, specificity as well as positive and negative predictive values are quite better. PCA3 test seems therefore to be a good indicator of prostate biopsy results. As a commercial kit is available, large studies will be conducted to confirm these results, precise when to perform the test and evaluate the benefit/cost ratio. One of the aims is better selection of those patients who will really benefit from prostate biopsies.