Pre-analytical in-vitro stability of [-2]proPSA in blood and serum

Semjonow, Axel; Köpke, Thomas; Eltze, Elke; Pepping-Schefers, B.; Bürgel, Hilla; Darte, Claude

doi:10.1016/j.clinbiochem.2010.04.062

Cited by 96 publications

(79 citation statements)

References 13 publications

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“…The PHI analyses were performed using Hybritech Calibrated AccessÒ assays (Beckman Coulter, Brea, California) 16 after processing with a UnicelÒ DxI 800 Immunoassay System analyzer (Beckman Coulter). All men underwent PCA3 testing before RB via a ProgensaÒ PCA3 assay (GenProbe Inc, San Diego, California) according to the manufacturer's specific instructions.…”

Section: Biomarkersmentioning

confidence: 99%

The Roles of Multiparametric Magnetic Resonance Imaging, PCA3 and Prostate Health Index—Which is the Best Predictor of Prostate Cancer after a Negative Biopsy?

et al. 2014

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Purpose: In patients with a negative prostate biopsy and persistent suspicion of prostate cancer, additional analyses such as the PCA3 score, PHI and multiparametric magnetic resonance imaging have been proposed to reduce the number of unnecessary repeat biopsies. In this study we evaluate the diagnostic accuracy of PCA3, PHI, multiparametric magnetic resonance imaging and various combinations of these tests in the repeat biopsy setting. Materials and Methods: A total of 170 patients with an initial negative prostate biopsy and persistent suspicion of prostate cancer were enrolled in this prospective study. The patients underwent measurements of the total prostate specific antigen and free prostate specific antigen rate, along with PHI, PCA3 tests and multiparametric magnetic resonance imaging before standard repeat biopsy that was performed by urologists blinded to the multiparametric magnetic resonance imaging results. Multivariate logistic regression models with various combinations of PCA3, PHI and multiparametric magnetic resonance imaging were used to identify the predictors of prostate cancer with repeat biopsy, and the performance of these models was compared using ROC curves, AUC analysis and decision curve analysis. Results: In the ROC analysis the most significant contribution was provided by multiparametric magnetic resonance imaging (AUC 0.936), which was greater than the contribution of the PHIþPCA3 model (p <0.001). In the multivariate logistic regression analysis only multiparametric magnetic resonance imaging was a significant independent predictor of prostate cancer diagnosis with repeat biopsy (p <0.001). The results of the decision curve analysis confirmed that the most significant improvement in the net benefit was provided by multiparametric magnetic resonance imaging.

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Section: Biomarkersmentioning

confidence: 99%

The Roles of Multiparametric Magnetic Resonance Imaging, PCA3 and Prostate Health Index—Which is the Best Predictor of Prostate Cancer after a Negative Biopsy?

et al. 2014

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“…Blood was drawn at each participating site and serum samples were prepared and frozen at Ϫ20 to Ϫ80°C within 3 h of blood collection according to recommendations for preanalytic tPSA and fPSA (19 ) and p2PSA as previously published (20 ). All blood samples were obtained before any manipulations involving the prostate and at least 3 weeks after a digital rectal examination (DRE).…”

Section: Methodsmentioning

confidence: 99%

Multicenter Evaluation of [−2]Proprostate-Specific Antigen and the Prostate Health Index for Detecting Prostate Cancer

et al. 2013

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BACKGROUND Total prostate-specific antigen (tPSA) is flawed for prostate cancer (PCa) detection. [−2]proprostate-specific antigen (p2PSA), a molecular isoform of free PSA (fPSA), shows higher specificity compared with tPSA or percentage of free PSA (%fPSA). The prostate health index (Phi), a measure based on p2PSA and calculated as p2PSA/fPSA × √tPSA, was evaluated in a multicenter study for detecting PCa. METHODS A total of 1362 patients from 4 different study sites who had tPSA values of 1.6–8.0 μg/L (668 patients with PCa, 694 without PCa) underwent ≥10 core biopsies. Serum concentrations of tPSA, fPSA (both calibrated against a WHO reference material), and p2PSA were measured on Access2 or DxI800 analyzers (Beckman Coulter). RESULTS The percentage ratio of p2PSA to fPSA (%p2PSA) and Phi were significantly higher in all PCa subcohorts (positive initial or repeat biopsy result or negative digital rectal examination) (P < 0.0001) compared with patients without PCa. Phi had the largest area under the ROC curve (AUC) (AUC = 0.74) and provided significantly better clinical performance for predicting PCa compared with %p2PSA (AUC = 0.72, P = 0.018), p2PSA (AUC = 0.63, P < 0.0001), %fPSA (AUC = 0.61) or tPSA (AUC = 0.56). Significantly higher median values of Phi were observed for patients with a Gleason score ≥7 (Phi = 60) compared with a Gleason score <7 (Phi = 53; P = 0.0018). The proportion of aggressive PCa (Gleason score ≥7) increased with the Phi score. CONCLUSIONS The results of this multicenter study show that Phi, compared with tPSA or %fPSA, demonstrated superior clinical performance in detecting PCa at tPSA 1.6–8.0 μg/L (i.e., approximately 2–10 μg/L in traditional calibration) and is better able to detect aggressive PCa.

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“…Serum samples were centrifuged and frozen at À20 or À80°C within at least 3 h after blood drawing due to the low stability of p2PSA in serum [29]. The serum samples were analysed on Access2-instruments in M€ unster and Berlin and on DxI800-instruments in Rennes and Paris using WHO-standard-calibration on the t-PSA and f-PSA assays.…”

Section: Methodsmentioning

confidence: 99%

The percentage of prostate‐specific antigen (PSA) isoform [–2]proPSA and the Prostate Health Index improve the diagnostic accuracy for clinically relevant prostate cancer at initial and repeat biopsy compared with total PSA and percentage free PSA in men aged ≤65 years

Boegemann¹,

Stephan

Cammann

et al. 2015

BJU International

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ObjectivesTo prospectively test the diagnostic accuracy of the percentage of prostate specific antigen (PSA) isoform [-2]proPSA (%p2PSA) and the Prostate Health Index (PHI), and to determine their role for discrimination between significant and insignificant prostate cancer at initial and repeat prostate biopsy in men aged ≤65 years. Patients and MethodsThe diagnostic performance of %p2PSA and PHI were evaluated in a multicentre study. In all, 769 men aged ≤65 years scheduled for initial or repeat prostate biopsy were recruited in four sites based on a total PSA (t-PSA) level of 1.6-8.0 ng/mL World Health Organization (WHO) calibrated (2-10 ng/mL Hybritechcalibrated). Serum samples were measured for the concentration of t-PSA, free PSA (f-PSA) and p2PSA with Beckman Coulter immunoassays on Access-2 or DxI800 instruments. PHI was calculated as (p2PSA/f-PSA 9 √t-PSA). Uni-and multivariable logistic regression models and an artificial neural network (ANN) were complemented by decision curve analysis (DCA). ResultsIn univariate analysis %p2PSA and PHI were the best predictors of prostate cancer detection in all patients In multivariate analysis PHI we added to a base model of age, prostate volume, digital rectal examination, t-PSA and %f-PSA. PHI was strongest in predicting prostate cancer in all patients, at initial and repeat biopsy and for significant prostate cancer (AUC 0.73, 0.68, 0.78 and 0.72, respectively). In DCA for all patients the ANN showed the broadest threshold probability and best net benefit. PHI as single parameter and the base model + PHI were equivalent with threshold probability and net benefit nearing those of the ANN. For significant cancers the ANN was the strongest parameter in DCA. ConclusionThe present multicentre study showed that %p2PSA and PHI have a superior diagnostic performance for detecting prostate cancer in the PSA range of 1.6-8.0 ng/mL compared with t-PSA and %f-PSA at initial and repeat biopsy and for predicting significant prostate cancer in men aged ≤65 years. They are equally superior for counselling patients before biopsy.

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Pre-analytical in-vitro stability of [-2]proPSA in blood and serum

Cited by 96 publications

References 13 publications

The Roles of Multiparametric Magnetic Resonance Imaging, PCA3 and Prostate Health Index—Which is the Best Predictor of Prostate Cancer after a Negative Biopsy?

The Roles of Multiparametric Magnetic Resonance Imaging, PCA3 and Prostate Health Index—Which is the Best Predictor of Prostate Cancer after a Negative Biopsy?

Multicenter Evaluation of [−2]Proprostate-Specific Antigen and the Prostate Health Index for Detecting Prostate Cancer

The percentage of prostate‐specific antigen (PSA) isoform [–2]proPSA and the Prostate Health Index improve the diagnostic accuracy for clinically relevant prostate cancer at initial and repeat biopsy compared with total PSA and percentage free PSA in men aged ≤65 years

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