The prostate health index and the percentage of [-2]proPSA maintain their diagnostic performance when calculated with total and free PSA from different manufacturers

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Manuel M. Garrido ◽  
Ruy Ribeiro ◽  
Luís C. Pinheiro ◽  
Stefan Holdenrieder ◽  
João T. Guimarães
Keyword(s):  
Prostate Cancer ◽  
Statistical Analysis ◽  
Diagnostic Performance ◽  
Univariate Analysis ◽  
Health Index ◽  
Predictive Values ◽  
Free Psa ◽  
Clinical Laboratories ◽  
Prostate Health Index ◽  
Prostate Health

Abstract Objectives To evaluate the diagnostic performance of the prostate health index (PHI) and of the percentage of [-2]proPSA (%[-2]proPSA) calculated with total and free PSA from non-Beckman Coulter manufacturers (Roche and Abbott), and compare it with the fully Beckman Coulter [-2]proPSA derivatives. Methods In this study, 237 men (PSA: 2–10 μg/L) scheduled for prostate biopsy were enrolled. %[-2]proPSA and PHI were calculated with total and free PSA from three manufacturers. Beckman Coulter PSA and [-2]proPSA were performed on the Access 2 analyzer (Hybritech calibration). Roche PSA was performed on the cobas e411 and the Abbott PSA on the Architect i2000sr. Statistical analysis was performed, considering prostate cancer (PCa) as the outcome. Results Univariate analysis showed that all indices were predictors of cancer, irrespective of the manufacturer (p<0.001). The AUC was similar for all manufacturers, both for %[-2]proPSA (Beckman Coulter: 0.756; Roche: 0.770; Abbott: 0.756) and PHI (Beckman Coulter: 0.776; Roche: 0.785; Abbott: 0.778). When considering the cutoffs that allowed 90% sensitivity, [-2]proPSA derivatives calculated with Roche and Abbott PSA had similar specificities and predictive values when compared to Beckman Coulter. The percentage of missed cancers (8–9%) was the same between manufacturers. The percentage of spared biopsies was significantly higher with Roche’s PHI (21.0%) and Abbott’s PHI (20.6%) than with Beckman Coulter’s PHI (17.2%). Conclusions In the PSA range between 2 and 10 μg/L, [-2]proPSA derivatives maintain their diagnostic performance in PCa detection when calculated with PSA from Roche and Abbott. This can lead to a broader implementation of these indices in clinical laboratories worldwide.

scholarly journals Usefulness of the prostate health index in predicting the presence and aggressiveness of prostate cancer among Korean men: a prospective observational study

BMC Urology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jae Yoon Kim ◽  
Ji Hyeong Yu ◽  
Luck Hee Sung ◽  
Dae Yeon Cho ◽  
Hyun-Jung Kim ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Observational Study ◽  
Prospective Observational Study ◽  
Specific Antigen ◽  
Significant Proportion ◽  
Health Index ◽  
Free Psa ◽  
Prostate Health Index ◽  
Total Psa ◽  
Prostate Health

Abstract Background We aimed to evaluate the usefulness of the Beckman Coulter prostate health index (PHI) and to compare it with total prostate-specific antigen (PSA) levels and related derivatives in predicting the presence and aggressiveness of prostate cancer (PCa) in the Korean population. Methods A total of 140 men who underwent their first prostate biopsy for suspected PCa were included in this prospective observational study. The diagnostic performance of total PSA, free PSA, %free PSA, [–2] proPSA (p2PSA), %p2PSA, and PHI in detecting and predicting the aggressiveness of PCa was estimated using the receiver operating characteristic curve (ROC) and logistic multivariate regression analyses. Results Of 140 patients, PCa was detected in 63 (45%) of participants, and 48 (76.2%) of them had significant cancer with a Gleason score (GS) ≥ 7. In the whole group, the area under the curve (AUC) for ROC analysis of tPSA, free PSA, %fPSA, p2PSA, %p2PSA, and PHI were 0.63, 0.57, 0.69, 0.69, 0.72, and 0.76, respectively, and the AUC was significantly greater in the PHI group than in the tPSA group (p = 0.005). For PCa with GS ≥ 7, the AUCs for tPSA, free PSA, %fPSA, p2PSA, %p2PSA, and PHI were 0.62, 0.58, 0.41, 0.79, 0.86, and 0.87, respectively, and the AUC was significantly greater in the PHI group than in the tPSA group (p < 0.001). In the subgroup with tPSA 4–10 ng/mL, both %p2PSA and PHI were strong independent predictors for PCa (p = 0.007, p = 0.006) and significantly improved the predictive accuracy of a base multivariable model, including age, tPSA, fPSA and %fPSA, using multivariate logistic regression analysis. (p = 0.054, p = 0.048). Additionally, at a cutoff PHI value > 33.4, 22.9% (32/140) of biopsies could be avoided without missing any cases of aggressive cancer. Conclusions This study shows that %p2PSA and PHI are superior to total PSA and %fPSA in predicting the presence and aggressiveness (GS ≥ 7) of PCa among Korean men. Using PHI, a significant proportion of unnecessary biopsies can be avoided.

The performance of [-2]proPSA and prostate health index tumor markers in prostate cancer diagnosis

2016 ◽  
Vol 40 (6) ◽  
Author(s):  
Joško Osredkar ◽  
Kristina Kumer ◽  
Teja Fabjan ◽  
Gregor Hlebič ◽  
Blaže Podnar ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Tumor Markers ◽  
Specific Antigen ◽  
Area Under The Curve ◽  
Health Index ◽  
Free Psa ◽  
Prostate Health Index ◽  
Prostatic Diseases ◽  
Total Psa ◽  
Prostate Health

AbstractBackground:Prostate-specific antigen (PSA) is an established tumor marker for the diagnosis of patients with prostate cancer. The aim of the study was to evaluate the performance of [-2]proenzyme PSA ([-2]proPSA) and prostate health index (PHI) tumor markers in the differential diagnosis between benign prostatic diseases and prostate cancer.Methods:Total PSA (tPSA), free PSA (fPSA) and [-2]proPSA were measured usingResults:For the prediction of a malignant histopathological result, the specificity at the 90% sensitivity level was 24.3% for [-2]proPSA, 32.4% for %[-2]proPSA, 28.4% for PHI, 18.9% for tPSA and 28.4% for the free-to-total PSA ratio. The area under the curve for [-2]proPSA, %[-2]proPSA, PHI, tPSA and the free-to-total PSA ratio was 0.663, 0.749, 0.742, 0.616 and 0.625, respectively.Conclusions:Our study found a moderate improvement over tPSA and %fPSA in detecting prostate cancer using the [-2]proPSA assay in patients with a tPSA range of 1.6–8.0 µg/L.

scholarly journals Comparative Assessment of Urinary Prostate Cancer Antigen 3 and TMPRSS2:ERG Gene Fusion with the Serum [−2]Proprostate-Specific Antigen–Based Prostate Health Index for Detection of Prostate Cancer

2013 ◽  
Vol 59 (1) ◽  
pp. 280-288 ◽  
Author(s):  
Carsten Stephan ◽  
Klaus Jung ◽  
Axel Semjonow ◽  
Kai Schulze-Forster ◽  
Henning Cammann ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prostate Biopsy ◽  
Gene Fusion ◽  
Specific Antigen ◽  
Health Index ◽  
Cancer Antigen ◽  
Free Psa ◽  
Prostate Health Index ◽  
Prostate Cancer Antigen ◽  
Prostate Health

BACKGROUND We compared urinary prostate cancer antigen 3 (PCA3), transmembrane protease, serine 2 (TMPRSS2):v-ets erythroblastosis virus E26 oncogene homolog (avian) (ERG) gene fusion (T2:ERG), and the serum [−2]proprostate-specific antigen ([−2]proPSA)-based prostate health index (Phi) for predicting biopsy outcome. METHODS Serum samples and first-catch urine samples were collected after digital rectal examination (DRE) from consented outpatients with PSA 0.5–20 μg/L who were scheduled for prostate biopsy. The PCA3 score (PROGENSA PCA3, Hologic Gen-Probe) and T2:ERG score (Hologic Gen-Probe) were determined. Measurements of serum PSA, free PSA, and [−2]proPSA (Beckman Coulter) were performed, and the percentages of free PSA (%fPSA) and Phi ([−2]proPSA/fPSA × √PSA) were determined. RESULTS Of 246 enrolled men, prostate cancer (PCa) was diagnosed in 110 (45%) and there was no evidence of malignancy (NEM) in 136 (55%). A first set of biopsies was performed in 136 (55%) of all men, and 110 (45%) had ≥1 repeat biopsies. PCA3, Phi, and T2:ERG differed significantly between men with PCa and NEM, and these markers showed the largest areas under the ROC curve (AUCs) (0.74, 0.68, and 0.63, respectively). PCA3 had the largest AUC of all parameters, albeit not statistically different from Phi. Phi showed somewhat lower specificities than PCA3 at 90% sensitivity. Combination of both markers enhanced diagnostic power with modest AUC gains of 0.01–0.04. Although PCA3 had the highest AUC in the repeat-biopsy cohort, the highest AUC for Phi was observed in DRE-negative patients with PSA in the 2–10 μg/L range. CONCLUSIONS PCA3 and Phi were superior to the other evaluated parameters but their combination gave only moderate enhancements in diagnostic accuracy for PCa at first or repeat prostate biopsy.

Use of [-2]proPSA and prostate health index (phi) to improve the diagnostic accuracy of prostate cancer compared to t-PSA and %f-PSA in young men (≤ 65 years old).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5074-5074
Author(s):  
Martin Boegemann ◽  
Sebastien Vincendeau ◽  
Carsten Stephan ◽  
Alain Houlgatte ◽  
Laura-Maria Krabbe ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Multicenter Study ◽  
Clinical Performance ◽  
Univariate Analysis ◽  
Specific Antigen ◽  
Digital Rectal Examination ◽  
Young Men ◽  
Health Index ◽  
Prostate Health Index ◽  
Prostate Health

5074 Background: Although prostate-specific antigen (tPSA) screening reduced prostate cancer (PCa) mortality recent recommendations do not endorse PSA-screening due to overdiagnosis and overtreatment and the resulting harm afflicted to patients. Screening studies showed the maximum benefit in young men < 65 years of age. tPSA and percent free PSA (%fPSA) lack specifity in the diagnosis of PCa. [-2]proPSA and the prostate health index (phi) improved this diagnostic specifity. Markers to diagnose clinicaly relevant cancers in young men are needed. Methods: The clinical performance of [-2]proPSA and phi was evaluated in a multicenter study. A total of 1362 patients scheduled for initial or repeated prostate biopsy (668 with, 694 without PCa, each ≥ 10 core biopsies) were recruited in 4 different sites based on PSA level 1.6 – 8.0 ng/mL WHO-calibrated (2-10 ng/mL classically calibrated). Serum samples taken prior to digital rectal examination (DRE) were measured for the concentration of tPSA, fPSA and [-2]proPSA with Beckman Coulter immunoassays on Access 2 or DxI800 instruments. Phi was calculated as [-2]proPSA/fPSA*√tPSA. Results: In univariate analysis [-2]proPSA/fPSA (%[-2]proPSA) and phi were the best predictors of PCa detection in patients at initial biopsy (AUC: 0,72 and 0,73) and repeated biopsy (AUC: 0,74 and 0,74). Analysis of the data for men ≤ 65 years of age (n=593) showed that %[-2]proPSA and phi significantly improved PCa dectection (AUC: 0,72 and 0,73) as compared with tPSA (AUC: 0,54) or %fPSA (AUC: 0,62). In the detection of significant PCa (based on PRIAS criteria) %[-2]proPSA and phi demonstrated the best performance in the whole cohort and in young men (≤ 65) years as well (AUC 0,68 and 0,73). Conclusions: This multicenter study showed that [-2]proPSA and phi have a superior clinical performance in detecting PCa in the PSA range of 2-10 ng/mL compared with tPSA and %fPSA at initial and repeated biopsies. This superiority is maintained for the detection of PCa in young men (≤ 65 years of age).

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

2013 ◽  
Vol 59 (1) ◽  
pp. 306-314 ◽  
Author(s):  
Carsten Stephan ◽  
Sébastien Vincendeau ◽  
Alain Houlgatte ◽  
Henning Cammann ◽  
Klaus Jung ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Gleason Score ◽  
Multicenter Study ◽  
Clinical Performance ◽  
Specific Antigen ◽  
Digital Rectal Examination ◽  
Health Index ◽  
Free Psa ◽  
Prostate Health Index ◽  
Prostate Health

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 &lt; 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 &lt; 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 &lt;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.

scholarly journals Usefulness of the Prostate Health Index in Predicting the Presence and Aggressiveness of Prostate Cancer Among Korean Men

2021 ◽  
Author(s):  
Jae-Yoon Kim ◽  
Ji-Hyeong Yu ◽  
Luck-Hee Sung ◽  
Dae-Yeon Cho ◽  
Hyun-Jung Kim ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Predictive Accuracy ◽  
Specific Antigen ◽  
Significant Proportion ◽  
Multivariate Logistic Regression Analysis ◽  
Health Index ◽  
Free Psa ◽  
Prostate Health Index ◽  
Total Psa ◽  
Prostate Health

Abstract BackgroundWe aimed to evaluate the usefulness of the Beckman Coulter prostate health index (PHI) and compare it with total prostate specific antigen (PSA) and related derivatives in predicting the presence and aggressiveness of prostate cancer (PCa) in the Korean population.MethodsA total of 140 men who underwent their first prostate biopsy for suspected PCa were included in this prospective observational study. The diagnostic performance of total PSA, free PSA, %free PSA, [–2] proPSA (p2PSA), %p2PSA, and PHI in detecting and predicting the aggressiveness of PCa was estimated using the receiver operating characteristic curve (ROC) and logistic multivariate regression analyses.ResultsOf 140 patients, PCa was detected in 63 (45%), and 48 (76.2%) of them had significant cancer with a Gleason score (GS) ≥7. In the whole group, the area under the curve (AUC) for ROC analysis of tPSA, free PSA, %fPSA, p2PSA, %p2PSA, and PHI were 0.63, 0.57, 0.69, 0.69, 0.71, and 0.75, respectively, and the AUC was significantly greater in the PHI group than in the tPSA group (p = 0.005). For PCa with GS ≥7, the AUCs for tPSA, free PSA, %fPSA, p2PSA, %p2PSA, and PHI were 0.62, 0.58, 0.41, 0.79, 0.87, and 0.88, respectively, and the AUC was significantly greater in the PHI group than in the tPSA group (p < 0.001). In the subgroup with tPSA 4–10 ng/mL, both %p2PSA and PHI were strong independent predictors for PCa (p = 0.031, p = 0.027) and significantly improved the predictive accuracy of a base multivariable model including age, tPSA, and %fPSA, using multivariate logistic regression analysis. (p = 0.015, p = 0.010). Additionally, at a cutoff PHI value >33.4, unnecessary biopsy could be avoided in 22.9% (32/140) cases, with no aggressive cancer patients missed.ConclusionThis study shows that %p2PSA and PHI are superior to total PSA and %fPSA in predicting the presence and aggressiveness (GS≥7) of PCa among Korean men. Using PHI, a significant proportion of unnecessary biopsies can be avoided.

scholarly journals The validation results for APhiGT algorithm for clarification of prostate cancer staging before treatment (first step)

2019 ◽  
Vol 15 (2) ◽  
pp. 42-52 ◽  
Author(s):  
N. S. Sergeeva ◽  
T. E. Skachkova ◽  
N. V. Marshutina ◽  
K. M. Nushko ◽  
I. M. Shevchuk ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Gleason Score ◽  
Specific Antigen ◽  
Area Under The Curve ◽  
Cancer Staging ◽  
Health Index ◽  
Free Psa ◽  
Prostate Health Index ◽  
Total Psa ◽  
Prostate Health

Background. We have previously described an algorithm APhiGT (Age, Prostate Health index, Gleason score, TNM stage) for staging of prostate cancer (PC) before treatment. The algorithm was developed by logistic regression on an educational selection (ES) of 337 PC cases. The algorithm includes data about the age of patients, the levels of total prostate-specific antigen (PSA), free PSA, [-2]proPSA and the ranked data of the Gleason score (by biopsy results) and T (by TNM).Objective. Validation of APhiGT on the validation selection (VS) of 83 PC cases was carried out in this work.Materials and methods. ROC analysis was performed in ES and VS.Results and сonclusion. It is established that area under the curve (AUC), characterizing the ability to divide clinically significant subgroups of patients (Gleason score <7 vs. Gleason score ≥7, рТ2 vs. рТ3, localized indolent PC vs. localized aggressive PC) for APhiGT both in ES and VS was significantly higher than AUC for total PSA, %[-2]proPSA in free PSA and prostate health index. At the same time, in all clinical subgroups of patients AUC for VS was lower than AUC for ES, which may be due to a significantly smaller size of VS compared to ES.

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