Accuracy Of Prostate Health Index Research Articles

Based on PI-RADS v2.1 combining PHI and ADC values to guide prostate biopsy in patients with PSA 4-20 ng/mL.

The study aimed to investigate the diagnostic accuracy of prostate health index (PHI) and apparent diffusion coefficient (ADC) values in predicting prostate cancer (PCa) and construct a nomogram for the prediction of PCa and clinically significant PCa (CSPCa) in Prostate Imaging-Reporting and Data System (PI-RADS) three lesions cohort. This study prospectively enrolled 301 patients who underwent multiparametric magnetic resonance (mpMRI) and were scheduled for prostate biopsy. The receiver operating characteristic curve (ROC) was performed to estimate the diagnostic accuracy of each predictor. Univariable and multivariable logistic regression analysis was conducted to ascertain hidden risk factors and constructed nomograms in PI-RADS three lesions cohort. In the whole cohort, the area under the ROC curve (AUC) of PHI is relatively high, which is 0.779. As radiographic parameters, the AUC of PI-RADS and ADC values was 0.702 and 0.756, respectively. The utilization of PHI and ADC values either individually or in combination significantly improved the diagnostic accuracy of the basic model. In PI-RADS three lesions cohort, the AUC for PCa was 0.817 in the training cohort and 0.904 in the validation cohort. The AUC for CSPCa was 0.856 in the training cohort and 0.871 in the validation cohort. When applying the nomogram for predicting PCa, 50.0% of biopsies could be saved, supplemented by 6.9% of CSPCa being missed. PHI and ADC values can be used as predictors of CSPCa. The nomogram included PHI, ADC values and other clinical predictors demonstrated an enhanced capability in detecting PCa and CSPCa within PI-RADS three lesions cohort.

Comparisons of the diagnostic accuracy across prostate health index, prostate health index density, and percentage free prostate-specific antigen for clinically significant prostate cancer: a prospective diagnostic study.

As the novel serum biomarkers, it has not been clearly clarified that the diagnostic accuracy of prostate health index (PHI) and prostate health index density (PHID) are superior to that of percentage free prostate-specific antigen (%fPSA) in detection of clinically significant prostate cancer (csPCa), especially in the gray zone. Therefore, this study aimed to compare the diagnostic value of PHI, PHID, and %fPSA for csPCa in the patients with prostate-specific antigen (PSA) >4 ng/mL and those with PSA within 4-10 ng/mL. In this study, the serum samples and clinicopathological features were prospectively obtained from the patients who underwent prostate biopsy between September 2019 and December 2020. According to the inclusion criteria, the patients with total PSA (tPSA) >4 ng/mL, prostate magnetic resonance imaging or ultrasound clearly suggesting an occupying lesion were enrolled in this study. The patients with Gleason score ≥7 indicated csPCa. The receiver operating characteristic curves and the area under the curve (AUC) values were used to assess the diagnostic performance. Among the 296 patients (mean age 67.5 years, median tPSA 7.94 ng/mL) included in this study, there were 54 in the csPCa group (mean age 70.4 years, median tPSA 11.0 ng/mL) and 242 in the non-csPCa group (mean age 66.8 years, median tPSA 7.67 ng/mL). Based on the PSA level, there were 198 patients with PSA within the gray zone, which included 40 patients in the csPCa group and 158 in the non-csPCa group. In all patients, the sensitivity of PHID for detecting csPCa was 96.30%, and the specificity was 33.06% with the cut-off value of 0.51. Moreover, both PHID and PHI did better in the diagnosis of csPCa (AUC: 0.880 and 0.867, respectively) compared with other PSA derivative markers. Similarly, in the patients with PSA level in the gray zone, the diagnostic accuracy of PHID and PHI in predicting csPCa (AUC: 0.788 and 0.777, respectively) were better than other PSA derivative markers. PHID presented the better diagnostic accuracy in predicting csPCa in patients with PSA in the gray zone than other PSA derivative markers, which could be a promising biomarker for making the biopsy strategy.

Abstract A066: Performance of the prostate health index (PHI) assay in black men

Abstract Introduction: The low specificity of PSA in prostate cancer (PCa) screening has caused excessive biopsies and PCa over-detection. PHI is more specific for clinically significant (cs) PCa (i.e. Gleason >6 PCa) and includes serum PSA, [-2]proPSA, and free PSA in its formula. Validation studies in diverse populations have suggested that PHI should be used as a reflex test and the optimal cutoffs for PHI vary across ethnic groups, but have not been determined in Black men. We sought to 1) assess the distributions of PHI and PSA in healthy controls and men with high-grade PCa and 2) assess the accuracy of PHI vs. PSA for detection of csPCa in Black men with elevated PSA. Methods: The present study population consists of two biopsy-naïve cohorts. The first cohort serves as healthy controls and includes Black men with PHI and PSA drawn at community screening events through the social networks of eight lay Black male Citizen Scientists. The second PHI Biopsy Study cohort consists of Black men referred with elevated PSA and/or abnormal digital rectal exam (DRE) who had PHI drawn immediately before prostate biopsy. We excluded men with prior biopsies or known PCa. Distributions of PHI and PSA were compared across controls and men with negative biopsies, Gleason 6 PCa and csPCa. Among men with biopsy, we compared the area under the receiver operating characteristics curves (AUC) for PSA and PHI for detecting csPCa and assessed specificity at selected sensitivities as a proxy of avoided biopsies. We descriptively assessed theoretically avoided biopsies and missed csPCa at previously established PHI cut points [27.0, 28.6, 29.9, and 35.0]. Results: For the first objective, 139 men (42.5%) were included as controls from the Citizens Scientist Study and 188 (57.5%) were from the PHI Biopsy Study cohort, out of which 82 (43.6%) had a negative biopsy for PCa, 40 (21.1%) had low-grade PCa, and 66 (35.1%) had a Gleason >6 PCa. Compared to the healthy control group, the PHI Biopsy Study cohort was older (median age 61 vs. 55 years), with higher PSA levels (7.1ng/mL vs. 0.9ng/mL) and PHI scores (61.1 vs. 20.1), and more commonly had a family history of PCa (19.4% vs. 5.0%) and benign prostatic hyperplasia diagnosis (21.3% vs. 2.2%) (all p<0.001). Relative to PSA, PHI has a higher degree of overlap in the distribution between controls and csPCas (p <0.05), suggesting PHI would not perform well as a primary screening test in Blacks. In men with PSA between 4-10, PHI outperformed PSA in the detection of HGPCa with an AUC of 0.70 (95% CI: 0.59-0.81) compared to 0.57 (95% CI: 0.46-0.69). As a reflex test in men with PSA of 4-10ng/mL and normal DRE, a PHI cutoff of 35.0 would spare 20 (27.8%) low-risk men a biopsy while missing 2 (7.4%) csPCas. Conclusion: PHI should not be used for primary screening but has higher accuracy and specificity than PSA in Black men with PSA levels of 4-10ng/mL as a reflex test. At a cutoff of 35.0, 28% of low-risk men avoid biopsy while missing 7% of csPCas. Citation Format: Samuel Carbunaru, Oluwarotimi Nettey, Edward M Schaeffer, Peter H Gann, Michael Abern, Courtney M.P Hollowell, Karriem Watson, Tiffany McDowell, Rick A Kittles, Adam B Murphy. Performance of the prostate health index (PHI) assay in black men [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr A066.

Measurement of serum isoform [–2]proPSA derivatives shows superior accuracy to magnetic resonance imaging in the diagnosis of prostate cancer in patients with a total prostate-specific antigen level of 2–10 ng/ml

Objective: More accurate diagnostic procedures for prostate cancer are needed to avoid unnecessary biopsy due to the low specificity of prostate-specific antigen (PSA). Recent studies showed that the percentage of serum isoform [–2]proPSA (p2PSA) to free PSA (%p2PSA), the Prostate Health Index (PHI) and magnetic resonance imaging (MRI) were more accurate than PSA. The aim of this study was to test the accuracy of %p2PSA, PHI and MRI in discriminating patients with and without prostate cancer.Materials and methods: The subjects were 50 consecutive men with a PSA level of 2.0–10.0 ng/ml, who underwent prostate biopsy from October 2012 to July 2014. These patients underwent multiparametric MRI before biopsy, and their serum samples were measured for PSA, free PSA and p2PSA. The sensitivity, specificity and accuracy of PHI, %p2PSA and MRI were compared with PSA in the diagnosis of biopsy-confirmed prostate cancer.Results: In a univariate analysis, %p2PSA [area under the curve (AUC): 0.811] and PHI (AUC 0.795) were more accurate than MRI (AUC: 0.583) and PSA (AUC: 0.554) for prostate cancer detection. At 60% sensitivity, the specificity of PHI (76.5%) was higher than that of MRI (52.9%). For significant cancer detection, %p2PSA (AUC: 0.745), PHI (AUC: 0.791) and MRI (AUC: 0.739) were marginally more accurate than PSA (AUC: 0.696). At 85% sensitivity, the specificity of MRI (62.1%) was higher than that of PHI (34.5%).Conclusion: PHI and %p2PSA can be used for screening the general population and MRI can be used for detection of significant cancer in patients suspected, from screening tests, of having prostate cancer.

A Systematic Review and Meta-analysis of the Diagnostic Accuracy of Prostate Health Index and 4-Kallikrein Panel Score in Predicting Overall and High-grade Prostate Cancer.

Markers for prostate cancer (PCa) have progressed over recent years. In particular, the prostate health index (PHI) and the 4-kallikrein (4K) panel have been demonstrated to improve the diagnosis of PCa. We aimed to review the diagnostic accuracy of PHI and the 4K panel for PCa detection. We performed a systematic literature search of PubMed, EMBASE, Cochrane, and Academic One File databases until July 2016. We included diagnostic accuracy studies that used PHI or 4K panel for the diagnosis of PCa or high-grade PCa. The methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. Twenty-eight studies including 16,762 patients have been included for the analysis. The pooled data showed a sensitivity of 0.89 and 0.74 for PHI and 4K panel, respectively, for PCa detection and a pooled specificity of 0.34 and 0.60 for PHI and 4K panel, respectively. The derived area under the curve (AUC) from the hierarchical summary receiver operating characteristic (HSROC) showed an accuracy of 0.76 and 0.72 for PHI and 4K panel respectively. For high-grade PCa detection, the pooled sensitivity was 0.93 and 0.87 for PHI and 4K panel, respectively, whereas the pooled specificity was 0.34 and 0.61 for PHI and 4K panel, respectively. The derived AUC from the HSROC showed an accuracy of 0.82 and 0.81 for PHI and 4K panel, respectively. Both PHI and the 4K panel provided good diagnostic accuracy in detecting overall and high-grade PCa.

Diagnostic accuracy of prostate health index to identify aggressive prostate cancer. An Institutional validation study

IntroductionNew generations of tumor markers used to detect prostate cancer (PCa) should be able to discriminate men with aggressive PCa of those without PCa or nonaggressive tumors. The objective of this study has been to validate Prostate Health Index (PHI) as a marker of aggressive PCa in one academic institution. MethodsPHI was assessed in 357 men scheduled to prostatic biopsy between June of 2013 and July 2014 in one academic institution. Thereafter a subset of 183 men younger than 75 years and total PSA (tPSA) between 3.0 and 10.0ng/mL, scheduled to it first prostatic biopsy, was retrospectively selected for this study. Twelve cores TRUS guided biopsy, under local anesthesia, was performed in all cases. Total PSA, free PSA (fPSA), and [-2]proPSA (p2PSA) and prostate volume were determined before the procedure and %fPSA, PSA density (PSAd) and PHI were calculated. Aggressive tumors were considered if any Gleason 4 pattern was found. PHI was compared to %fPSA and PSAd through their ROC curves. Thresholds to detect 90%, 95% of all tumors and 95% and 100% of aggressive tumors were estimated and rates of unnecessary avoided biopsies were calculated and compared. ResultsThe rate of PCa detection was 37.2% (68) and the rate of aggressive tumors was 24.6% (45). The PHI area under the curve was higher than those of %fPSA and PSAd to detect any PCa (0.749 vs. 0.606 and 0.668 respectively) or to detect only aggressive tumors (0.786 vs. 0.677 and 0.708 respectively), however, significant differences were not found. The avoided biopsy rates to detect 95% of aggressive tumors were 20.2% for PHI, 14.8% for %fPSA, and 23.5% for PSAd. Even more, to detect all aggressive tumors these rates dropped to 4.9% for PHI, 9.3% for %fPSA, and 7.9% for PSAd. ConclusionsPHI seems a good marker to PCa diagnosis. However, PHI was not superior to %fPSA and PSAd to identify at least 95% of aggressive tumors.

Prognostic accuracy of Prostate Health Index and urinary Prostate Cancer Antigen 3 in predicting pathologic features after radical prostatectomy

ObjectiveTo compare the prognostic accuracy of Prostate Health Index (PHI) and Prostate Cancer Antigen 3 in predicting pathologic features in a cohort of patients who underwent radical prostatectomy (RP) for prostate cancer (PCa). Methods and materialsWe evaluated 156 patients with biopsy-proven, clinically localized PCa who underwent RP between January 2013 and December 2013 at 2 tertiary care institutions. Blood and urinary specimens were collected before initial prostate biopsy for [-2] pro–prostate-specific antigen (PSA), its derivates, and PCA3 measurements. Univariate and multivariate logistic regression analyses were carried out to determine the variables that were potentially predictive of tumor volume >0.5ml, pathologic Gleason sum≥7, pathologically confirmed significant PCa, extracapsular extension, and seminal vesicles invasions. ResultsOn multivariate analyses and after bootstrapping with 1,000 resampled data, the inclusion of PHI significantly increased the accuracy of a baseline multivariate model, which included patient age, total PSA, free PSA, rate of positive cores, clinical stage, prostate volume, body mass index, and biopsy Gleason score (GS), in predicting the study outcomes. Particularly, to predict tumor volume>0.5, the addition of PHI to the baseline model significantly increased predictive accuracy by 7.9% (area under the receiver operating characteristics curve [AUC] = 89.3 vs. 97.2, P>0.05), whereas PCA3 did not lead to a significant increase.Although both PHI and PCA3 significantly improved predictive accuracy to predict extracapsular extension compared with the baseline model, achieving independent predictor status (all P׳s<0.01), only PHI led to a significant improvement in the prediction of seminal vesicles invasions (AUC = 92.2, P<0.05 with a gain of 3.6%).In the subset of patients with GS≤6, PHI significantly improved predictive accuracy by 7.6% compared with the baseline model (AUC = 89.7 vs. 97.3) to predict pathologically confirmed significant PCa and by 5.9% compared with the baseline model (AUC = 83.1 vs. 89.0) to predict pathologic GS≥7. For these outcomes, PCA3 did not add incremental predictive value. ConclusionsIn a cohort of patients who underwent RP, PHI is significantly better than PCA3 in the ability to predict the presence of both more aggressive and extended PCa.

Serum testosterone improves the accuracy of Prostate Health Index for the detection of prostate cancer

ObjectiveProstate cancer (PCa) detection suffers from low specificity when using the prostate-specific antigen (PSA) alone. The aim of this study was to investigate the applicability of total testosterone (tT), free testosterone (fT), the fraction (%) of fT to tT (%fT), and bioavailable testosterone (bioT) in serum to improve the diagnostic validity of the serum (−2)pro-PSA-based Prostate Health Index (PHI). Design and methodsTotal and free PSA (tPSA, fPSA), (−2)pro-PSA, testosterone, and sex-hormone-binding globulin were measured by automated immunoassays from serum of 193 men scheduled for prostate biopsy (99 PCa, 94 without PCa). fT and bioT were calculated using an online calculator. Statistical analyses were performed by non-parametric tests (Wilcoxon signed rank, Mann–Whitney, Kruskal–Wallis), binary logistic regression, and receiver operating characteristic (ROC) analyses. ResultsCompared with the non-malignant controls, PCa patients had significantly higher tPSA concentrations and PHI values, but lower %fPSA values and lower concentrations of tT, fT, and bioT. PCa could be differentiated from controls by PHI, tT, fT, bioT, and %fPSA. PHI showed the largest area under the ROC curve (AUC=0.73) that was increased further by the inclusion of bioT or tT in a binary logistic regression model. The AUC of PHI in patients with tT concentrations of <8nmol/L (indicating biochemical hypogonadism) was significantly larger than that in patients with higher tT values (0.86 vs. 0.70; P=0.024). ConclusionsThe PHI-based discrimination between PCa patients and non-malignant controls could be improved by the simultaneous determination of testosterone. Patients with testosterone concentrations of <8nmol/L have the greatest benefit.