Prostate Health Index Density Research Articles

Utility of Prostate Health Index Density for Biopsy Strategy in Biopsy-Naïve Patients With PI-RADS v2.1 Category 3 Lesions.

Category 3 lesions in PI-RADSv2.1 pose diagnostic challenges, complicating biopsy decisions. Recent biomarkers like prostate health index (PHI) have shown higher specificity in detecting clinically significant prostate cancer (csPCa) than prostate-specific antigen (PSA). Yet their integration with MRI remains understudied. To evaluate the utility of PSA and PHI with its derivatives for detecting csPCa in biopsy-naïve patients with category 3 lesion on initial prostate MRI scan. Retrospective. One hundred ninety-three biopsy-naïve patients who underwent MRI, PSA, and PHI testing, followed by both targeted and systematic biopsies. Turbo spin-echo T2-weighted imaging, diffusion-weighted single-shot echo-planar imaging, and dynamic contrast-enhanced T1-weighted fast field echo sequence imaging in 3 T. PHI density (PHID) and PSA density (PSAD) derived by dividing serum PHI and PSA with prostate volume (MRI based methodology suggested by PI-RADSv2.1). Risk-stratified models to evaluate the utility of markers in triaging patients for biopsy, including low-, intermediate-, and high-risk groups. Independent t-test, Mann-Whitney U test, Mantel-Haenszel test, generalized estimating equation, and receiver operating characteristic (ROC) curve analysis were used. Statistical significance defined as P < 0.05. CsPCa was found in 16.6% (32/193) of patients. PHID had the highest area under the ROC curve (AUROC) of 0.793, followed by PHI of 0.752, PSAD of 0.750, and PSA of 0.654. PHID with two cut-off points (0.88/mL and 1.82/mL) showed the highest potential biopsy avoidance of 47.7% (92/193) with 5% missing csPCa, and the lowest intermediate-risk group (borderline decision group) at 38.9% (75/193), compared to PSA and PHI. PHID demonstrated better potential in triaging patients with category 3 lesions, possibly aiding more selective and confident biopsy decisions for csPCa detection, than traditional markers. 4 TECHNICAL EFFICACY: Stage 5.

The Value of the Prostate Health Index and Derived Indexes in the Diagnosis of Prostate Cancer with PI-RADS-3 Lesions

Introduction: The purpose of this article was to evaluate the diagnostic value of prostate health index (PHI) and its derivatives in prostate cancer (PCa) with prostate imaging reporting and data system (PI-RADS)-3 lesions. Methods: Patients with benign prostatic hyperplasia (BPH) (n = 155) were included in the BPH group, while all patients with PCa (n = 49) were enrolled in the PCa group. Between the groups, the serum concentrations of total prostate-specific antigen (TPSA), percent-free prostate-specific antigen (%fPSA), prostate health index (PHI), prostate health index density (PHID), and prostate-specific antigen density (PSAD) were compared. Results: On average, 49 (24%) of 204 men had PCa on biopsy, with 81.63% of those cases being clinically serious. Age, prostate volume, TPSA, and PSAD did not significantly differ between the PCa group and the BPH group. In contrast, [-2]pro prostate-specific antigen (p2PSA) (17.10 ± 4.77 vs. 13.93 ± 3.22, p < 0.001), PHI (33.88 ± 8.81 vs. 25.83 ± 5.63, p < 0.001), and PHID (0.52 ± 0.15 vs. 0.38 ± 0.11, p < 0.001) showed a statistically significant difference between the two groups. Compared to conventional PSA, PHI (AUC = 0.786, 95% CI: 0.705–0.867) and PHID (AUC = 0.763, 95% CI: 0.684–0.843) were considerably better predictors of all PCa. The TPSA, %fPSA, p2PSA, PHI, PHID, and PSAD areas under the receiver operating characteristic for clinically significant PCa (csPCa) were 0.587, 0.650, 0.696, 0.823, 0.796, and 0.614, respectively. Out of all the various parameters, PHI and PHID performed very well in this cohort’s biopsy outcome prediction. Conclusion: PHI offers the best diagnostic value for detecting PCa in cases of PI-RADS-3 lesions. Additionally, PHID raised the possibility of csPCa PI-RADS-3 lesions. However, more investigation is required to confirm our results by using multicenter collaboration.

How to avoid prostate biopsy in men with Prostate Image-Reporting and Data System 3 lesion? Development and external validation of new biopsy indication using prostate health index density.

To develop a customized prostate biopsy indication using prostate health index density (PHID) combined with multiparametric magnetic resonance imaging (mpMRI) and assess the reliability of the PHID cutoff value in external populations. A total of 521 cognitive MRI/ultrasonography fusion prostate biopsies and biomarker tests for prostate-specific antigen (PSA), free PSA, and PHI were performed after mpMRI. The predictive value for clinically significant prostate cancer (csPCa; Gleason score≥7) of PSA derivatives was examined using the ROC curve. We developed a new biopsy indication utilizing a PHID cutoff based on the Prostate Image-Reporting and Data System (PI-RADS) score, which was externally validated. The combination of PHID and mpMRI (AUC=0.884) demonstrated the highest predictive ability for csPCa, although PHID (AUC=0.843) and PI-RADS (AUC=0.806) individually also showed a high diagnostic value. When a PHID cutoff of 0.75 was used in men with PI-RADS 3 lesions, the negative predictive value of csPCa was 100%, and approximately half of the biopsies could be safely avoided. Compared to PHID or PI-RADS scores alone, the combination of PHID and PI-RADS scores increased the accuracy of csPCa detection and the number of cases in which biopsy could be avoided. In men with PI-RADS 3 lesions, the optimal PHID cutoff ≥0.75 can prevent half of the unnecessary biopsies without missing csPCa. In men with PI-RADS 4-5 lesions, biopsies are warranted regardless of PHID values because csPCa could be accompanied by low PHID.

Comparison of Prostate-Specific Antigen and Its Density and Prostate Health Index and Its Density for Detection of Prostate Cancer.

As the incidence of prostate cancer (PCa) has increased, screening based on prostate-specific antigen (PSA) has become controversial due to the low specificity of PSA. Therefore, we investigated the diagnostic performance of prostate health index (PHI) density (PHID) for the detection of PCa and clinically significant PCa (csPCa) compared to PSA, PSA density (PSAD), and PHI as a triaging test. We retrospectively reviewed 306 men who underwent prostate biopsy for PSA levels of 2.5 to 10 ng/mL between January 2020 and April 2023. Of all cohorts, 86 (28.1%) and 48 (15.7%) men were diagnosed with PCa and csPCa, respectively. In ROC analysis, the highest AUC was identified for PHID (0.812), followed by PHI (0.791), PSAD (0.650), and PSA (0.571) for PCa. A similar trend was observed for csPCa: PHID (AUC 0.826), PHI (AUC 0.796), PSAD (AUC 0.671), and PSA (0.552). When the biopsy was restricted to men with a PHID ≥ 0.56, 26.5% of unnecessary biopsies could be avoided; however, 9.3% of PCa cases and one csPCa case (2.1%) remained undiagnosed. At approximately 90% sensitivity for csPCa, at the given cut-off values of PHI ≥ 36.4, and PHID ≥ 0.91, 48.7% and 49.3% of unnecessary biopsies could be avoided. In conclusion, PHID had a small advantage over PHI, about 3.6%, for the reduction in unnecessary biopsies for PCa. The PHID and PHI showed almost the same diagnostic performance for csPCa detection. PHID can be used as a triaging test in a clinical setting to pre-select the risk of PCa and csPCa.

The Journal of Urology® Home Study Course 2023 Volume 209/210.

The Journal of Urology® Home Study Course 2023 Volume 209/210.

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Editorial Comment.

No AccessJournal of UrologyAdult Urology4 May 2023Editorial Comment Claire M. de la Calle and Christian P. Pavlovich Claire M. de la CalleClaire M. de la Calle The Brady Urological Institute and Department of Urology, Johns Hopkins School of Medicine, Baltimore, Maryland More articles by this author and Christian P. PavlovichChristian P. Pavlovich The Brady Urological Institute and Department of Urology, Johns Hopkins School of Medicine, Baltimore, Maryland More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003450.01AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareFacebookLinked InTwitterEmail "Editorial Comment." The Journal of Urology, Publish Ahead of Print, pp. REFERENCES 1. Prostate Health Index density outperforms prostate-specific antigen density in the diagnosis of clinically significant prostate cancer in equivocal magnetic resonance imaging of the prostate: a multicenter evaluation. J Urol. 2023; 210(1):000. Google Scholar 2. Combining Prostate Health Index density, magnetic resonance imaging and prior negative biopsy status to improve the detection of clinically significant prostate cancer. BJU Int. 2018; 121(4):619-626. Crossref, Medline, Google Scholar 3. Optimizing patient's selection for prostate biopsy: a single institution experience with multi-parametric MRI and the 4Kscore test for the detection of aggressive prostate cancer. PLoS One. 2018; 13(8):e0201384. Crossref, Medline, Google Scholar 4. Avoiding unnecessary magnetic resonance imaging (MRI) and biopsies: negative and positive predictive value of MRI according to prostate-specific antigen density, 4Kscore and risk calculators. Eur Urol Oncol. 2020; 3(5):700-704. Crossref, Medline, Google Scholar © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Claire M. de la Calle The Brady Urological Institute and Department of Urology, Johns Hopkins School of Medicine, Baltimore, Maryland More articles by this author Christian P. Pavlovich The Brady Urological Institute and Department of Urology, Johns Hopkins School of Medicine, Baltimore, Maryland More articles by this author Expand All Advertisement PDF downloadLoading ...

Prostate Health Index Density Outperforms Prostate-specific Antigen Density in the Diagnosis of Clinically Significant Prostate Cancer in Equivocal Magnetic Resonance Imaging of the Prostate: A Multicenter Evaluation.

We compare Prostate Health Index, Prostate Health Index density, and PSA density in predicting clinically significant prostate cancer in MRI-guided prostate biopsy. This is a multicenter evaluation of prospectively maintained prostate biopsy databases at 10 urology centers. Men with Prostate Health Index and MRI-guided targeted and systematic prostate biopsy performed and without prior prostate cancer diagnosis were included. The additional value of PSA density, Prostate Health Index, and Prostate Health Index density to MRI PI-RADS (Prostate Imaging Reporting & Data System) score was evaluated with multivariable analyses, area under the curve, and decision curve analyses. The proportion of unnecessary biopsies that can be avoided are estimated for clinically significant prostate cancer (International Society of Urological Pathology group ≥2 prostate cancer). A total of 1,215 men were analyzed. Prostate cancer and clinically significant prostate cancer were diagnosed in 51% (617/1,215) and 35% (422/1,215) of men, respectively. Clinically significant prostate cancer was diagnosed in 4.4% (3/68), 15% (72/470), 39% (176/446), and 74% (171/231) of highest PI-RADS score of 2, 3, 4, and 5 lesions, respectively. In multivariable analyses, independent predictors for clinically significant prostate cancer detection included Prostate Health Index (OR 1.04), prostate volume (OR 0.97), and PI-RADS score 4 (OR 2.81) and 5 (OR 8.34). Area under the curve for clinically significant prostate cancer of PI-RADS + Prostate Health Index density (0.85) was superior to PI-RADS + PSA density (0.81), Prostate Health Index density (0.81), Prostate Health Index (0.78), PI-RADS (0.76), PSA density (0.72), and PSA (0.60) in the whole cohort, and the superiority of Prostate Health Index density was also observed in PI-RADS 3 lesions. Decision curve analysis showed Prostate Health Index density achieving the best net clinical benefit in PI-RADS 3 or 4 cases. Among PI-RADS 3 lesions, using cutoffs of PSA density 0.15, Prostate Health Index 38.0, and Prostate Health Index density 0.83 could reduce 58%, 67%, and 72% of unnecessary biopsies, respectively. Prostate Health Index density outperformed Prostate Health Index or PSA density in clinically significant prostate cancer detection in men with multiparametric MRI performed, and further reduced unnecessary biopsies in PI-RADS 3 lesions.

MP40-20 CAN WE PREDICT FOR MISSED CLINICALLY SIGNIFICANT PROSTATE CANCERS ON MRI-TARGETED BIOPSY ALONE?

You have accessJournal of UrologyCME1 Apr 2023MP40-20 CAN WE PREDICT FOR MISSED CLINICALLY SIGNIFICANT PROSTATE CANCERS ON MRI-TARGETED BIOPSY ALONE? Woon Chau Tsang, Kaiying Wang, Abner Quek, Ziting Wang, Edmund Chiong, and Qinghui Wu Woon Chau TsangWoon Chau Tsang More articles by this author , Kaiying WangKaiying Wang More articles by this author , Abner QuekAbner Quek More articles by this author , Ziting WangZiting Wang More articles by this author , Edmund ChiongEdmund Chiong More articles by this author , and Qinghui WuQinghui Wu More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003278.20AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: MRI-Targeted prostate biopsy (TBx) strategy has been shown to diagnose more clinically significant prostate cancer (csPCa) and less clinically insignificant prostate cancer (ciPCa). Currently, the yield of systematic or saturation biopsy in addition to TBx remains remain unclear. This study aims to evaluate for factors that may predict for csPCa that are missed on TBx alone. METHODS: From 2015 to 2022, we collected prospective single-centre data of consecutive patients who underwent prostate biopsy. We included patients who were biopsy-naïve, had prior negative biopsies, or were on active surveillance for low risk prostate cancer. mpMRI-ultrasound fusion-guided robotic-assisted TBx was performed for every lesion of Prostate Imaging Reporting and Data System (PIRADS) 3 and above, and every patient additionally received saturation biopsy (SBx). Patient data, MRI lesion characteristics, PIRADS score and biopsy results were evaluated. csPCa was defined as ISUP grade group 2 and above. RESULTS: 499 men underwent combined TBx and SBx. The median serum PSA was 7.31ug/L. The overall cancer detection rate was 65.7%, where csPCa rate was 45.1%. The overall cancer and csPCa rates for TBx only vs TBx plus SBx, was 52.9% vs 65.7% (p<0.01), and 39.9% vs 45.1% (p=0.10) respectively. If only TBx was performed, 19.5% of all cancers and 11.5% of csPCa would have been missed. Patients with missed csPCa on TBx only had lower PSA (7.75 vs 10.6, p<0.01), higher prostate volume (59.5 vs 42.9cc, p=0.04), and lower PSA density (0.164 vs 0.271, p<0.01). They also had lower prostate health index (PHI) score (50.6 vs 61.9, p=0.04), although PHI density was similar (1.22 vs 1.56, p=0.09). A smaller index lesion diameter was also predictive of missed csPCa on TBx (8.70 vs 12.2 mm, p<0.01). Patients with PIRADS 3 index lesions were more likely to have missed csPCa on TBx than PIRADS 4 and 5, with a missed csPCa rate of 25.8% vs 11.8% vs 3.45% (p<0.01) respectively. Age, number of lesions on mpMRI, and indication for biopsy were not predictive of missed csPCa. CONCLUSIONS: In our series, TBx alone strategy can miss 11.5% of csPCa. Factors predictive of missed csPCa include initial low PSA level, larger prostate volume, low PSA density, low PHI, small index lesion diameter and lower PIRADS score of the index lesion. A nomogram is created to aid decision making on patient selection to omit systematic biopsy when performing TBx. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e553 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Woon Chau Tsang More articles by this author Kaiying Wang More articles by this author Abner Quek More articles by this author Ziting Wang More articles by this author Edmund Chiong More articles by this author Qinghui Wu More articles by this author Expand All Advertisement PDF downloadLoading ...

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.

Do PHI and PHI density improve detection of clinically significant prostate cancer only in the PSA gray zone?

Prostate health index (PHI) is a predictive biomarker of positive prostate biopsy. The majority of evidence refers to its use in the PSA gray zone (4-10ng/mL) and negative digital rectal exam (DRE). We aim to evaluate and compare the predictive accuracy of PHI and PHI density (PHId) with PSA, percentage of free PSA and PSA density, in a wider range of patients for the detection of clinically significant prostate cancer (csPCa). Multicenter prospective study that included patients suspicious of harboring prostate cancer. Non-probabilistic convenience sampling, where men who attended the urology consultation were tested for PHI before prostate biopsy. To evaluate and compare diagnostic accuracy AUC and decision curve analysis (DCA) were calculated. All these procedures were performed for the overall sample and the following subsamples: PSA<4ng/ml; PSA 4-10ng/ml; PSA 4-10ng/ml plus negative DRE and PSA>10ng/ml. Among the 559 men included, 194 (34.7%) were diagnosed of csPCa. PHI and PHId outperfomed PSA in all subgroups. PHI best diagnostic performance was found in PSA 4-10ng/ml with negative DRE (sensitivity 93.33, NPV 96.04). Regarding AUC, significant differences were found between PHId and PSA in the subgroup of PSA 4-10ng/ml, whatever DRE status. In DCA, PHI density shows the highest net benefit. PHI and PHId outperfom PSA in csPCa detection, not only in the PSA grey zone with negative DRE, but also in a wider range of PSA values. There is an urgent need of prospective studies to established a validated threshold and its incorporation in risk calculators.

A prospective study of the prostate health index density and multiparametric magnetic resonance imaging in diagnosing clinically significant prostate cancer.

To evaluate the predictive performance of the prostate health index (PHI) and PHI density (PHID), for clinically significant prostate cancer (csPCa) in patients with a PI-RADS score ≤3. Patients tested for total prostate-specific antigen (tPSA, ≤100 ng/mL), free PSA (fPSA), and p2PSA at Peking University First Hospital were prospectively enrolled. Possible predictive factors of csPCa were analyzed using the receiver operating characteristic (ROC) curve. Results were expressed as area under the curve (AUC) with 95% confidence intervals (CI). The cutoff values of PHI and PHID were determined. We enrolled 222 patients in this study. The prevalence of csPCa in the PI-RADS ≤3 subgroup (n=89) was 22.47% (20/89). Age, tPSA, F/T, prostate volume, PSA density, PHI, PHID, and PI-RADS score were significantly associated with csPCa. PHID (AUC: 0.829 [95% CI: 0.717-0.941]) was the best predictor of csPCa. PHID >0.956 was set as the threshold of suspicious csPCa with a sensitivity of 85.00% and a specificity of 73.91%, avoiding 94.44% of unnecessary biopsies but missing 15.00% csPCa. A threshold of PHI ≥52.83 showed the same sensitivity but a rather lower specificity of 65.22% that avoided 93.75% of unnecessary biopsies. PHI and PHID have the best predictive performance of csPCa in patients with PI-RADS score ≤3. A threshold value of PHID ≥0.956 may be used as the criterion for biopsy in these patients.

Evaluating the Role of Morphological Parameters in the Prostate Transition Zone in PHI-Based Predictive Models for Detecting Gray Zone Prostate Cancer.

The early detection of clinically significant prostate cancer (csPCa) through the integration of multidimensional parameters presents a promising avenue for improving survival outcomes for this fatal disease. This study aimed to assess the contribution of prostate transition zone (TZ) to predictive models based on the prostate health index (PHI), with the goal of enhancing early detection of csPCa in the prostate-specific antigen (PSA) gray zone. In this observational cross-sectional study, a total of 177 PSA gray zone patients (total prostate-specific antigen [tPSA] level ranging from 4.0 to 10.0 ng/mL) were recruited and received PHI detections from August 2020 to March 2022. Prostatic morphologies especially the TZ morphological parameters were measured by transrectal ultrasound (TRUS). Univariable logistic regression indicated prostatic morphological parameters including total prostate volume (PV) indexes and transitional zone volume indexes were all associated with csPCa (P < .05), while the multivariable analysis demonstrated that C-reactive protein (CRP), PHI, PHI density (PHID), and PHI transition zone density (PHI-TZD) were the 4 independent risk factors. The receiver-operating characteristic (ROC) curve analysis suggested that integrated predictive models (PHID, PHI-TZD) yield area under the curves (AUCs) of 0.9135 and 0.9105 in csPCa prediction, which shows a relatively satisfactory predictive capability compared with other predictors. Moreover, the PHI-TZD outperformed PHID by avoiding 30 patients' unnecessary biopsies while maintaining 74.36% specificity at a sensitivity of 90%. Decision-curve analysis (DCA) confirmed the comparable performance of the multivariable full-risk prediction models, without the inclusion of the net benefit, thereby highlighting the superior diagnostic efficacy of PHID and PHI-TZD in comparison with other diagnostic models, in both univariable and multivariable models. Our data confirmed the value of prostate TZ morphological parameters and suggested a significant advantage for the TZ-adjusted PHI predictive model (PHI-TZD) compared with PHI and PHID in the early detection of gray zone csPCa under specific conditions.

Nomograms Combining PHI and PI-RADS in Detecting Prostate Cancer: A Multicenter Prospective Study

(1) Background: The study aimed to construct nomograms to improve the detection rates of prostate cancer (PCa) and clinically significant prostate cancer (CSPCa) in the Asian population. (2) Methods: This multicenter prospective study included a group of 293 patients from three hospitals. Univariable and multivariable logistic regression analysis was performed to identify potential risk factors and construct nomograms. Discrimination, calibration, and clinical utility were used to assess the performance of the nomogram. The web-based dynamic nomograms were subsequently built based on multivariable logistic analysis. (3) Results: A total of 293 patients were included in our study with 201 negative and 92 positive results in PCa. Four independent predictive factors (age, prostate health index (PHI), prostate volume, and prostate imaging reporting and data system score (PI-RADS)) for PCa were included, and four factors (age, PHI, PI-RADS, and Log PSA Density) for CSPCa were included. The area under the ROC curve (AUC) for PCa was 0.902 in the training cohort and 0.869 in the validation cohort. The AUC for CSPCa was 0.896 in the training cohort and 0.890 in the validation cohort. (4) Conclusions: The combined diagnosis of PHI and PI-RADS can avoid more unnecessary biopsies and improve the detection rate of PCa and CSPCa. The nomogram with the combination of age, PHI, PV, and PI-RADS could improve the detection of PCa, and the nomogram with the combination of age, PHI, PI-RADS, and Log PSAD could improve the detection of CSPCa.

Prospective comparison of restriction spectrum imaging and non-invasive biomarkers to predict upgrading on active surveillance prostate biopsy.

Protocol-based active surveillance (AS) biopsies have led to poor compliance. To move to risk-based protocols, more accurate imaging biomarkers are needed to predict upgrading on AS prostate biopsy. We compared restriction spectrum imaging (RSI-MRI) generated signal maps as a biomarker to other available non-invasive biomarkers to predict upgrading or reclassification on an AS biopsy. We prospectively enrolled men on prostate cancer AS undergoing repeat biopsy from January 2016 to June 2019 to obtain an MRI and biomarkers to predict upgrading. Subjects underwent a prostate multiparametric MRI and a short duration, diffusion-weighted enhanced MRI called RSI to generate a restricted signal map along with evaluation of 30 biomarkers (14 clinico-epidemiologic features, 9 molecular biomarkers, and 7 radiologic-associated features). Our primary outcome was upgrading or reclassification on subsequent AS prostate biopsy. Statistical analysis included operating characteristic improvement using AUROC and AUPRC. The individual biomarker with the highest area under the receiver operator characteristic curve (AUC) was RSI-MRI (AUC = 0.84; 95% CI: 0.71-0.96). The best non-imaging biomarker was prostate volume-corrected Prostate Health Index density (PHI, AUC = 0.68; 95% CI: 0.53-0.82). Non-imaging biomarkers had a negligible effect on predicting upgrading at the next biopsy but did improve predictions of overall time to progression in AS. RSI-MRI, PIRADS, and PHI could improve the predictive ability to detect upgrading in AS. The strongest predictor of clinically significant prostate cancer on AS biopsy was RSI-MRI signal output.

Clinical Utility of Prostate Health Index for Diagnosis of Prostate Cancer in Patients with PI-RADS 3 Lesions.

Simple SummaryMulti-parametric magnetic resonance imaging (mpMRI) is regarded as an essential tool for identifying prostate cancer (PCa) in suspected cases. However, unnecessary biopsies continue to be performed in real clinics, especially for prostate imaging reporting and data system version 2 (PI-RADS v2) score-3 lesions, corresponding to the “gray zone”. To aid the diagnosis of PCa, as well as of clinically significant PCa (csPCa), in patients with PI-RADSv2 score-3 lesions, we evaluated the clinical utility of the prostate health index (PHI). When a biopsy was restricted to those patients with PI-RADSv2 score-3 lesions and a PHI of ≥30, 34.4% of unnecessary biopsies could be avoided at the cost of missing 8.3% of overall PCa cases. However, there were no cases of missed csPCa diagnosis. The combination of PHI and PI-RADSv2 score-3 lesions offered higher accuracy in the diagnosis of PCa as well as of csPCa.The risk of prostate cancer (PCa) in prostate imaging reporting and data system version 2 (PI-RADSv2) score-3 lesions is equivocal; it is regarded as an intermediate status of presented PCa. In this study, we evaluated the clinical utility of the prostate health index (PHI) for the diagnosis of PCa and clinically significant PCa (csPCa) in patients with PI-RADSv2 score-3 lesions. The study cohort included patients who underwent a transrectal ultrasound (TRUS)-guided, cognitive-targeted biopsy for PI-RADSv2 score-3 lesions between November 2018 and April 2021. Before prostate biopsy, the prostate-specific antigen (PSA) derivatives, such as total PSA (tPSA), [-2] proPSA (p2PSA) and free PSA (fPSA) were determined. The calculation equation of PHI is as follows: [(p2PSA/fPSA) × tPSA ½]. Using a receiver operating characteristic (ROC) curve analysis, the values of PSA derivatives measured by the area under the ROC curve (AUC) were compared. For this study, csPCa was defined as Gleason grade 2 or higher. Of the 392 patients with PI-RADSv2 score-3 lesions, PCa was confirmed in 121 (30.9%) patients, including 59 (15.1%) confirmed to have csPCa. Of all the PSA derivatives, PHI and PSA density (PSAD) showed better performance in predicting overall PCa and csPCa, compared with PSA (all p < 0.05). The AUC of the PHI for predicting overall PCa and csPCa were 0.807 (95% confidence interval (CI): 0.710–0.906, p = 0.001) and 0.819 (95% CI: 0.723–0.922, p < 0.001), respectively. By the threshold of 30, PHI was 91.7% sensitive and 46.1% specific for overall PCa, and was 100% sensitive for csPCa. Using 30 as a threshold for PHI, 34.4% of unnecessary biopsies could have been avoided, at the cost of 8.3% of overall PCa, but would include all csPCa.

Tissue expression of the antiapoptotic protein survinin as a potential biomarker of prostate cancer

Background. Excessive expression of survivin is associated with inhibition of cell death, activated by extrinsic or intrinsic apoptotic pathways. The survininin overexpression has been shown in various malignancies, including lung cancer, pancreatic and breast cancer, colon cancer, oral squamous cell carcinoma and high grade non-Hodgkin lymphomas.Aim. To investigate the level of survivin expression in prostate cancer tissues, and evaluate it as a diagnostic marker of prostate cancer.Materials and methods. The level of survivin expression and its subcellular localization were assessed immunohistochemically in patients with prostate cancer (n = 64) and benign prostatic hyperplasia (n = 33). Tissue samples obtained at transrectal biopsy were used for analysis. Prostate cancer samples obtained after cystprostatectomy in patients with normal prostate specific antigen level and normal ultrasound findings (n = 36) were considered control tissue (norm).Results. In prostate cancer group 3+ samples with a high level of survivin expression were present in 48.4 % of cases. In benign prostatic hyperplasia group the majority of samples were assessed as 2+, while 9.1 % of samples were negatively stained. 100 % of normal epithelium samples were negative. In patients with Gleason score &lt;7 a survivin expression level was less than 3+ in 62.5 % of cases, and in patients with Gleason score &gt;7 a highly positive reaction was detected in 68.8 % of cases. A high level of survivin expression was found in the large proportion of tissue samples at prostate specific antigen levels &gt;10 ng/ml. Almost 50 % of highly positive cells were detected at a prostate health index (PHI) value of ≥60. The largest percentage of negative staining for surviving was common with PHI value &lt;25. The degrees of staining for survining 1+ and 2+ prevailed in patients with prostate health index density (DPHI) &lt;0.8, while a high level of prostate cells staining 3+ was observed at &gt;0.8. As a Gleason score increase we observe the change of staining type for nucleocytoplasmic, and the largest number of samples has a staining degree of 2+ at a score GG4–5 (≥4 + 4). The type and frequency of prostate tissue samples staining were not differ depending on the initial prostate specific antigen level.Conclusion. Immunohistochemical assessment of the survivin level, including its subcellular localization, could be considered as tumor-associated and a potential biomarker for differential diagnosis and prediction of prostate cancer course.

Utility of serum biomarkers for predicting cancer in patients with previous negative prostate biopsy.

To review the role of serum biomarkers: prostate-specific antigen (PSA), PSA density (PSAD), free:total PSA ratio, prostate health index (PHI) and PHI density (PHID), along with magnetic resonance imaging (MRI) for identification of clinically significant prostate cancer (PCa), comparing their utility in patients with persistently raised PSA levels after a prior negative prostate biopsy (PNB). In this single-centre prospective observational study conducted from September 2015 to October 2020, patients underwent a saturation biopsy via the transperineal route. If a Prostate Imaging Reporting and Data System version 2 (PIRADS) 3 and above lesion was seen on MRI, targeted biopsies were also obtained. Information on clinical history, lesion characteristics, PIRADS classification and follow-up was collected. The sensitivity, specificity and area under curve (AUC) for each of the biomarkers were calculated. 351 men underwent saturation biopsy with or without targeted biopsies. 103 patients had a PNB. Among this PNB cohort, 43 (41.7%) men had a benign outcome, while 60 (58.3%) men had histopathologically diagnosed PCa, of which 41 (39%) were clinically significant. All patients underwent multiparametric MRI scans prior to biopsy. Within this cohort, PHI and PHID had the best abilities to predict for clinically significant PCa with an AUC of 0.73 and 0.70 respectively, compared to 0.65 for PSAD, 0.34 for free:total PSA and 0.56 for PSA. A significant proportion of patients are diagnosed with PCa after a PNB. This study shows that PHI and PHI densities may be suitable adjuncts predicting for clinically significant PCa in patients with PNB.

MP45-02 A PROSPECTIVE STUDY OF THE PROSTATE HEALTH INDEX DENSITY AND MULTIPARAMETRIC MAGNETIC RESONANCE IMAGING IN DIAGNOSING CLINICALLY SIGNIFICANT PROSTATE CANCER

You have accessJournal of UrologyCME1 May 2022MP45-02 A PROSPECTIVE STUDY OF THE PROSTATE HEALTH INDEX DENSITY AND MULTIPARAMETRIC MAGNETIC RESONANCE IMAGING IN DIAGNOSING CLINICALLY SIGNIFICANT PROSTATE CANCER Gang Song, and Yuanchong Chen Gang SongGang Song More articles by this author , and Yuanchong ChenYuanchong Chen More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002611.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To evaluate the predictive performance of the Prostate Health Index (PHI) and PHI density (PHID), for clinically significant PCa (csPCa) in patients with a Prostate Imaging Reporting and Data System (PI-RADS) score ≤ 3. METHODS: Patients tested for total prostate-specific antigen (tPSA, ≤ 100 ng/mL), free PSA (fPSA), and p2PSA at our institution were prospectively enrolled. Possible predictive factors of csPCa were analyzed using the receiver operating characteristic (ROC) curve. Results were expressed as area under the curve (AUC) with 95% confidence intervals (CI). The cutoff values of PHI and PHID were determined. RESULTS: We enrolled 204 patients in this study. The prevalence of csPCa in the PI-RADS ≤ 3 subgroup (N = 81) was 19.75% (16/81). Age, tPSA, F/T, prostate volume, PSA density, PHI, PHID, and PI-RADS score were significantly associated with csPCa. PHID (AUC: 0.841 [95% CI: 0.736–0.947]) was the best predictor of csPCa. PHID > 0.956 was set as the threshold of suspicious csPCa with a sensitivity of 87.50% and a specificity of 72.31%, avoiding 95.92% of unnecessary biopsies but missing 12.50% csPCa. A threshold of PHI ≥ 52.83 showed the same sensitivity but a rather lower specificity of 64.62% that avoided 95.45% of unnecessary biopsies. CONCLUSIONS: PHI and PHID have the best predictive performance of csPCa in patients with PI-RADS score ≤3. A threshold value of PHID ≥ 0.956 may be used as the criterion for biopsy in these patients. Source of Funding: Beckman Coulter © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e762 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Gang Song More articles by this author Yuanchong Chen More articles by this author Expand All Advertisement PDF DownloadLoading ...

MP43-04 COMPARISON OF 4K SCORE, PROSTATE HEALTH INDEX, AND PSA DENSITY IN ACTIVE SURVEILLANCE

You have accessJournal of UrologyCME1 May 2022MP43-04 COMPARISON OF 4K SCORE, PROSTATE HEALTH INDEX, AND PSA DENSITY IN ACTIVE SURVEILLANCE Bruce Trock, Mufaddal Mamawala, Patricia Landis, Yasin Bhanji, Andrew Vickers, and Christian Pavlovich Bruce TrockBruce Trock More articles by this author , Mufaddal MamawalaMufaddal Mamawala More articles by this author , Patricia LandisPatricia Landis More articles by this author , Yasin BhanjiYasin Bhanji More articles by this author , Andrew VickersAndrew Vickers More articles by this author , and Christian PavlovichChristian Pavlovich More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002609.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The 4Kscore combines levels of 4 kallikreins in blood with clinical factors as a measure of the risk of Grade Group [GG] ≥2 prostate cancer (PCa), while the Prostate Health Index (PHI) measures 3 kallikreins. No previous studies have directly compared the utility of 4Kscore, PHI and PSA density (PSAD) measured in the same men to predict biopsy outcomes on active surveillance (AS). We sought to compare the performance of the 3 biomarkers to predict grade reclassification (GR) to GG ≥2 in AS men. METHODS: We retrospectively evaluated 133 men with GG1 PCa in Johns Hopkins AS program who had 4Kscore, PHI, and PSA from the same blood sample taken prior to censoring or GR. Multivariable logistic regression was used to predict GR at the next follow-up biopsy (with MRI targeting of any region of interest). Because clinical cutpoints for these biomarkers have not been defined in the AS context, they were modeled as both continuous and dichotomized at the median in non-GR men. The area under the curve (AUC) and likelihood ratio test were used to compare improvement in performance when 4Kscore, PHI, or PSAD were added to a clinical model (age, number of prior biopsies, positive cores and maximum percent cancer in any core at prior biopsy). RESULTS: Of 133 men, 56 had GR. The median age at blood draw was 69 (IQR 65–73) with median follow-up 4 years (IQR 2–7). Men with GR had significantly higher PSAD (median 0.13 vs 0.09, p <0.001), PHI (median 37.3 vs 27.4, p <0.001) and 4Kscore (0.33 vs 0.17, p=0.001) compared to men without GR. The AUC of the clinical model was 0.811. As continuous variables none of the biomarkers were significant in the multivariable model, although all slightly increased AUCs: PSAD 0.817; PHI 0.821; 4Kscore 0.815. When dichotomized both PHI and 4Kscore significantly improved model fit vs clinical model (Table), and increased AUC: 0.829 and 0.814, respectively. CONCLUSIONS: This is the first direct comparison of 4Kscore and PHI in AS men. They provided minimal improvement in prediction of GR beyond clinical factors in men on AS, with potentially stronger effect when dichotomized. When a clinical model performs so well, biomarkers generally produce small increments in AUC, suggesting potential utility of this clinical model. Larger studies, potentially incorporating MRI findings are needed to determine the clinical utility of these markers in AS. Source of Funding: James Buchanan Brady Urological Institute © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e741 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Bruce Trock More articles by this author Mufaddal Mamawala More articles by this author Patricia Landis More articles by this author Yasin Bhanji More articles by this author Andrew Vickers More articles by this author Christian Pavlovich More articles by this author Expand All Advertisement PDF DownloadLoading ...