scholarly journals External validation of prostate health index-based nomogram for predicting prostate cancer at extended biopsy

2020 ◽  
Vol 148 (5-6) ◽  
pp. 292-298
Author(s):  
Milorad Stojadinovic ◽  
Damnjan Pantic ◽  
Miroslav Stojadinovic

Introduction/Objective. Prostate Health Index (PHI)-based nomograms were created by Lughezzani et al. (2012) and Zhu et al. (2015) for predicting prostate cancer (PCa) at extended biopsy. The aim of the study was to externally validate two nomograms in the Serbian population. Methods. This retrospective study comprised 71 patients irrespective of digital rectal examination (DRE) findings, with prostate-specific antigen level < 10 ng/ml, who had undergone prostate biopsies, and PHI testing. Data were collected in accordance with previous nomograms predictors. Independent predictors were identified by using logistic regression. The predictive accuracy was measured by the area under the receiver operating characteristic curve (AUC). The calibration belt was used to assess model calibration. The clinical utility was measured by using decision curve analysis (DCA). Results. There were numerous differences in underlying risk factors between validation dataset and previously available data. Analysis demonstrated that the DRE and PHI were independent predictors. AUCs for both nomograms, in patients with normal DRE had shown to have a good discriminatory ability (77.2?86.2%). In the entire population AUC of nomogram had exceptional discrimination (92.9%). Zhu et al. nomogram is associated with lower false positive predictions. The calibration belt for Zhu et al. nomogram was acceptable. Our DCA suggested that both nomograms are likely to be clinically useful. Conclusion. We performed external validation of two PHI-based nomograms predicting the presence of PCa in both the initial and the repeat biopsy setting. The PHI-based nomograms displayed adequate accuracy and justifies its use in Serbian patients.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5074-5074
Author(s):  
Martin Boegemann ◽  
Sebastien Vincendeau ◽  
Carsten Stephan ◽  
Alain Houlgatte ◽  
Laura-Maria Krabbe ◽  
...  

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).


2013 ◽  
Vol 59 (1) ◽  
pp. 306-314 ◽  
Author(s):  
Carsten Stephan ◽  
Sébastien Vincendeau ◽  
Alain Houlgatte ◽  
Henning Cammann ◽  
Klaus Jung ◽  
...  

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.


2021 ◽  
Author(s):  
Jae-Yoon Kim ◽  
Ji-Hyeong Yu ◽  
Luck-Hee Sung ◽  
Dae-Yeon Cho ◽  
Hyun-Jung Kim ◽  
...  

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.


BMC Urology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jae Yoon Kim ◽  
Ji Hyeong Yu ◽  
Luck Hee Sung ◽  
Dae Yeon Cho ◽  
Hyun-Jung Kim ◽  
...  

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.


2015 ◽  
Vol 5 (1) ◽  
Author(s):  
Yao Zhu ◽  
Cheng-Tao Han ◽  
Gui-Ming Zhang ◽  
Fang Liu ◽  
Qiang Ding ◽  
...  

2020 ◽  
Author(s):  
Vojtěch Novák ◽  
Štěpán Veselý ◽  
Hana Lukšanová ◽  
Richard Průša ◽  
Otakar Čapoun ◽  
...  

Abstract Background: We aimed to explore the utility of prostate specific antigen (PSA) isoform [-2]proPSA and its derivatives for prediction of pathological outcome after radical prostatectomy (RP).Methods: Preoperative blood samples were prospectively and consecutively analyzed from 472 patients treated with RP for clinically localized prostate cancer at four medical centers. Measured parameters were PSA, free PSA (fPSA), fPSA/PSA ratio, [-2]proPSA (p2PSA), p2PSA/fPSA ratio and Prostate Health Index (PHI) (p2PSA/fPSA)*√PSA]. Logistic regression models were fitted to determine the accuracy of markers for prediction of pathological Gleason score (GS) ≥7, Gleason score upgrading, extracapsular extension of the tumor (pT3) and the presence of positive surgical margin (PSM). Results: Of 472 patients undergoing RP, 339 (72%) were found to have pathologic GS ≥ 7, out of them 178 (53%) experienced an upgrade from their preoperative GS=6. The findings of pT3 and PSM were present in 132 (28%) and 133 (28%) cases, respectively. At univariable analysis of all the preoperative parameters, PHI was the most accurate predictor of pathological GS ≥7, GS upgrading, pT3 disease and the presence of PSM. Adding of PHI into the base multivariable model increased significantly the accuracy for prediction of pathological GS and GS upgrading by 4.4% (p=0.015) and 5.0% (p=0.025), respectively. Conclusion: We found that PHI provides the highest accuracy in predicting prostate cancer aggressiveness and expansion of the tumor detected at final pathology. The ability of PHI to predict the risk of Gleason score upgrade may help to identify potentially high-risk patients among men with biopsy proven insignificant prostate cancer.


2020 ◽  
Vol 2020 ◽  
pp. 1-11 ◽  
Author(s):  
Wei Jin ◽  
Xiang Fei ◽  
Xia Wang ◽  
Yan Song ◽  
Fangjie Chen

Prostate cancer (PCa) is second only to lung cancer as a cause of death. Clinical assessment of patients and treatment efficiency therefore depend on the disease being diagnosed as early as possible. However, due to issues regarding the use of prostate-specific antigen (PSA) for screening purposes, PCa management is among the most contentious of healthcare matters. PSA screening is problematic primarily because of diagnosis difficulties and the high rate of false-positive biopsies. Novel PCa biomarkers, such as the Prostate Health Index (PHI) and the 4Kscore, have been proposed in recent times to improve PSA prediction accuracy and have shown higher performance by preventing redundant biopsies. The 4Kscore also shows high precision in determining the risk of developing high-grade PCa, whereas elevated PHI levels suggest that the tumor is aggressive. Some evidence also supports the effectiveness of miRNAs as biomarkers for distinguishing PCa from benign prostatic hyperplasia and for assessing the aggressiveness of the disease. A number of miRNAs that possibly act as tumor inhibitors or oncogenes are impaired in PCa. These new biomarkers are comprehensively reviewed in the present study in terms of their potential use in diagnosing and treating PCa.


2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 203-203
Author(s):  
P. Sooriakumaran ◽  
M. John ◽  
J. Bektic ◽  
G. Bartsch ◽  
M. Herman ◽  
...  

203 Background: There are no published nomograms that predict prostate cancer in a screened population. We describe three nomograms that predict for prostate cancer on biopsy derived from a large screening population. Methods: Patients from the Tyrol screening study of known age, total prostate-specific antigen (tPSA), digital rectal examination (DRE), prostate volume, and percent free PSA (%fPSA), and who underwent an initial prostate biopsy from January 1992 to June 2004, were included (n=2271). Multivariable logistic regression models were used to develop the biopsy positivity predictive nomograms: nomogram 1- age, DRE, tPSA; nomogram 2- age, DRE, tPSA, prostate volume; nomogram 3- age, DRE, tPSA, prostate volume, %fPSA. The predictive accuracy of the models was assessed in terms of discrimination and calibration. External validation of the nomograms was performed by comparison with a urologically referred population of patients who underwent prostate biopsy (n=599). Results: All three nomograms discriminated well between biopsy positive and biopsy negative patients for both the screening and urologically referred cohorts (nomogram 3 better than nomogram 2 better than nomogram 1). All three nomograms were well calibrated internally, but the nomograms under-predicted the probability of a positive biopsy in the urologically referred cohort. Conclusions: Our nomogram based on age, total PSA, and DRE has a good predictive ability to differentiate between screened patients that will show cancer on initial prostate biopsy and those that will not. Adding prostate volume and percent free PSA improves this predictive power further. All three nomograms under-predict prostate cancer in a urologically referred cohort. These simple nomograms may be of value in counseling screened men with raised PSA and/or abnormal DRE regarding the need for biopsy. No significant financial relationships to disclose.


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