Extended analysis of a validated urine-exosome signature to predict high grade prostate cancer on initial biopsy: Performance across multiple sub-groups.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 42-42 ◽  
Author(s):  
Michael Donovan ◽  
Stefan Bentink ◽  
Mikkel Noerholm ◽  
Vince O'Neill ◽  
Johan Skog
Keyword(s):  
Prostate Cancer ◽  
Family History ◽  
African Americans ◽  
Gene Expression Signature ◽  
High Grade ◽  
Cut Point ◽  
Negative Biopsy ◽  
Initial Biopsy ◽  
Intended Use ◽  
Biopsy Rate

42 Background: We recently completed a prospective observational clinical trial of a first-catch urine exosome gene expression signature (ExoIntelliScore Prostate) to predict high-grade prostate cancer, HGPCA (>/=GS7) on initial biopsy. The assay accurately predicted HGPCA with an NPV>90% for an intended use popuation: men >/= 50 years with an equivocal PSA of 2-10 ng/mL presenting for their first biopsy. Given the current high prostate biopsy rate and potential impact of race, we sought to further understand performance of the assay by constructing sub-cohorts from the validation study. Methods: Utilizing the ExoIntelliScore Prostate result and clinical data from the 519 patient intended use clinical validation cohort (IU), we constructed several subgroups including: i. prior negative (A, n=149), ii. combined prior negative + initial biopsy (B, n=668) and African Americans, AA (C, n=87). Area under the curve (AUC), NPV, PPV, sensitivity and specificity with validated cut-point assess performance. Results: There was demographic comparability between the initial intended use (IU) and various subgroups, i.e., prior negative (A), combined prior negative and initial biopsy (B) and African Americans (C) with some exceptions observed (bold) for AA patients; family history (IU, 23%; A: 27%, B: 24%, C: 30%; positive biopsy rate (IU, 48%; A: 34%, B: 45%, C:52%; and >/= GS7 (IU, 28%; A: 13%, B: 27%; C: 34%). The AUC range for ExoIntelliscore Prostate + standard of care (i.e., age, race, PSA and family history) between IU and A, B subgroups was 0.72-0.74; AUC for AA was 0.62, except for prior negative biopsy AA patients, AUC 0.80; supporting importance of prior negative biopsy. Of note, applying the ExoIntelliscore Prostate cut-point, A, B yielded an NPV of 91%; including NPV of 89% for AA (initial biopsy) and NPV of 91% for AA with initial + prior negative biopsy. Conclusions: The ExoIntelliScore Prostate performed equally well in men with or without a prior negative biopsy with comparable results also seen for African Americans. Additional confirmatory studies with more patients is necessary to confirm initial observations.

scholarly journals  A Urine-Based Exosomal Gene Expression Test Stratifies Risk of High-Grade Prostate Cancer in Men with Prior Negative Prostate Biopsy Undergoing Repeat Biopsy

2020 ◽  
Author(s):  
James McKiernan ◽  
Mikkel Noerholm ◽  
Vasisht Tadigotla ◽  
Sonia Kumar ◽  
Phillipp Torkler ◽  
...  
Keyword(s):  
Gene Expression ◽  
Prostate Cancer ◽  
Clinical Features ◽  
Prostate Biopsy ◽  
Repeat Biopsy ◽  
Superior Performance ◽  
High Grade ◽  
Cut Point ◽  
Negative Biopsy ◽  
Initial Biopsy

Abstract BACKGROUND: Initial prostate biopsy often fails to identify prostate cancer resulting in patient anxiety, especially when clinical features such as prostate specific antigen (PSA) remain elevated, leading to the need for repeat biopsies. Prostate biomarker tests, such as the ExoDx™ Prostate(IntelliScore), or EPI test, have been shown to provide individualized risk assessment of clinically significant prostate cancer at initial biopsy; however, the performance in the repeat biopsy setting is not well established. Methods: As part of a previous prospective clinical validation study evaluating the performance of the EPI test, we collected first-catch, non-DRE urine samples across 22 sites from men with at least one prior negative biopsy scheduled to undergo a repeat prostate biopsy to rule out prostate cancer. All men were 50 years or older with a PSA 2-10ng/mL. Exosomal mRNA was extracted and expression of three genomic markers, PCA3, ERG and SPDEF was measured. The resulting EPI score was correlated with biopsy results. Results: 229 men with a prior negative biopsy underwent repeat biopsies. ExoDx Prostate demonstrated good performance ruling out high-grade (Grade group 2, GG2, or higher) prostate cancer (HGPCa) using the previously validated 15.6 cut point in the initial biopsy setting. The EPI test yielded an NPV of 92% independent of other clinical features and would have avoided 26% of unnecessary biopsies while missing only five patients with HGPCa (2.1%). Furthermore, the EPI test provided additional information at a cut-point of 20 and 29.6 with an NPV of 94%, potentially delaying 35% and 61% of unnecessary biopsies, respectively. AUC curves and Net Health Benefit Analyses demonstrated superior performance of ExoDx Prostate over PSA and clinical only risk calculators, i.e. ERSPC.Conclusions: The EPI test provided good performance using the 15.6 cut-point for ruling out HGPCa / GG2 or higher in men undergoing a repeat prostate biopsy with a PSA of 2-10ng/ml. Furthermore, the test utilizes gene expression data independent of clinical features to predict the likelihood of HGPCa / GG2 on a subsequent needle biopsy.

Performance of a clinically validated urine exosome gene expression test to predict high grade prostate cancer in men with a prior negative biopsy.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 119-119 ◽  
Author(s):  
Michael Joseph Donovan ◽  
Phillipp Torkler ◽  
Mikkel Noerholm ◽  
Johan Skog ◽  
James M McKiernan
Keyword(s):  
Gene Expression ◽  
Prostate Cancer ◽  
Family History ◽  
Positive Family History ◽  
Low Grade ◽  
High Grade ◽  
Patient Anxiety ◽  
Cut Points ◽  
Negative Biopsy ◽  
Initial Biopsy

119 Background: The over-diagnosis of low grade, indolent prostate cancer (PCa) initiates significant patient anxiety regarding treatment options and health risk. To address this clinical need, we developed and subsequently validated a noninvasive, easy to administer, supportive diagnostic test (ExoDx Prostate(IntelliScore), EPI) to guide the initial prostate biopsy decision process for men with PSA 2-10ng/mL. The EPI test is a urine exosome gene expression assay to discriminate high-grade (GS 7 PCa) from low-grade (GS 6) and benign disease, thereby potentially reducing the number of unnecessary biopsies. As many men have had prior negative/ benign biopsies, we sought to understand the performance of EPI in this selected population. Methods: Utilizing men with prior negative biopsies from two clinical trials we evaluated performance of the EPI test with respect to subsequent biopsy outcomes. We used the previously validated and alternative EPI cut-points of 15.6 and 20, respectively, to assess performance with AUC, sensitivity, and NPV. Results: A total of N = 286 patients with a prior negative biopsy; mean age 65 years, mean PSA 6.2 ng/mL, 22% positive family history, 15% African American; 32% positive biopsy rate: 20% GS6 (ISUP1) and 12% > / = GS7 PCa (ISUP≥2). AUC 0.68 vs. AUC 0.59 for standard of care (i.e. PSA, age, race, family history) and AUC 0.51 for PSA alone. By comparison the EPI initial biopsy AUC was 0.71. Using the previously validated EPI cut-points of 15.6 (or alternative 20) yielded NPVs of 92% and 95%, and number of avoided biopsies of 23% and 32%, respectively, and sensitivity of 85.7% for both cut-points. Notably, EPI in the initial biopsy setting had a sensitivity of 92 vs. 87% and an NPV of 91 vs. 90%, for the 15.6 and 20 cut-points, respectively. Conclusions: The EPI test is a noninvasive, first-catch, non-DRE gene expression array that accurately discriminates low-grade and benign biopsy outcomes from high-grade prostate cancer. The test performs well in both the initial and prior negative biopsy patients and has the potential to reduce the overall number of unnecessary biopsies in both settings.

scholarly journals A Urine-Based Exosomal Gene Expression Test Stratifies Risk of High-Grade Prostate Cancer in Men with Prior Negative Prostate Biopsy Undergoing Repeat Biopsy

2020 ◽  
Author(s):  
James McKiernan ◽  
Mikkel Noerholm ◽  
Vasisht Tadigotla ◽  
Sonia Kumar ◽  
Phillipp Torkler ◽  
...  
Keyword(s):  
Gene Expression ◽  
Prostate Cancer ◽  
Clinical Features ◽  
Prostate Biopsy ◽  
Specific Antigen ◽  
Repeat Biopsy ◽  
High Grade ◽  
Cut Point ◽  
Negative Biopsy ◽  
Initial Biopsy

Abstract Background : Initial prostate biopsy often fails to identify prostate cancer resulting in patient anxiety, especially when clinical features such as prostate specific antigen (PSA) remain elevated, leading to the need for repeat biopsies. Prostate biomarker tests, such as the ExoDx™ Prostate (IntelliScore) , or EPI test, have been shown to provide individualized risk assessment of clinically significant prostate cancer at initial biopsy; however, the performance in the repeat biopsy setting is not well established. Methods : As part of a previous prospective clinical validation study evaluating the performance of the EPI test, we collected first-catch, non-DRE urine samples across 22 sites from men with prior negative biopsy scheduled to undergo a repeat prostate biopsy to rule out prostate cancer. All men were 50 years or older with a PSA 2-10ng/mL. Exosomal mRNA was extracted and expression of three genomic markers, PCA3, ERG and SPDEF was measured. The resulting EPI score was correlated with biopsy results.Results : 229 men with a prior negative biopsy underwent repeat biopsies. ExoDx Prostate demonstrated good performance ruling out high-grade (Grade group 2, GG2, or higher) prostate cancer (HGPCa) using the previously validated 15.6 cut point in the initial biopsy setting. The EPI test yielded an NPV of 92% independent of other clinical features and would have avoided 26% of unnecessary biopsies while missing only five patients with HGPCa (2.1%). Furthermore, the EPI test provided additional information at a cut-point of 20 and 29.6 with an NPV of 94%, potentially delaying 35% and 61% of unnecessary biopsies, respectively. Conclusions : The EPI test provided good performance using the 15.6 cut-point for ruling out HGPCa / GG2 or higher in men undergoing a repeat prostate biopsy with a PSA of 2-10ng/ml. Furthermore, the test utilizes gene expression data independent of clinical features to predict the likelihood of HGPCa / GG2 on a subsequent needle biopsy.

scholarly journals A Urine-Based Exosomal Gene Expression Test Stratifies Risk of High-Grade Prostate Cancer in Men with Prior Negative Prostate Biopsy Undergoing Repeat Biopsy

2020 ◽  
Author(s):  
James McKiernan ◽  
Mikkel Noerholm ◽  
Vasisht Tadigotla ◽  
Sonia Kumar ◽  
Phillipp Torkler ◽  
...  
Keyword(s):  
Gene Expression ◽  
Prostate Cancer ◽  
Clinical Features ◽  
Prostate Biopsy ◽  
Repeat Biopsy ◽  
Superior Performance ◽  
High Grade ◽  
Cut Point ◽  
Negative Biopsy ◽  
Initial Biopsy

Abstract BACKGROUND: Initial prostate biopsy often fails to identify prostate cancer resulting in patient anxiety, especially when clinical features such as prostate specific antigen (PSA) remain elevated, leading to the need for repeat biopsies. Prostate biomarker tests, such as the ExoDx™ Prostate(IntelliScore), or EPI test, have been shown to provide individualized risk assessment of clinically significant prostate cancer at initial biopsy; however, the performance in the repeat biopsy setting is not well established. Methods: As part of a previous prospective clinical validation study evaluating the performance of the EPI test, we collected first-catch, non-DRE urine samples across 22 sites from men with at least one prior negative biopsy scheduled to undergo a repeat prostate biopsy to rule out prostate cancer. All men were 50 years or older with a PSA 2-10ng/mL. Exosomal mRNA was extracted and expression of three genomic markers, PCA3, ERG and SPDEF was measured. The resulting EPI score was correlated with biopsy results. Results: 229 men with a prior negative biopsy underwent repeat biopsies. ExoDx Prostate demonstrated good performance ruling out high-grade (Grade group 2, GG2, or higher) prostate cancer (HGPCa) using the previously validated 15.6 cut point in the initial biopsy setting. The EPI test yielded an NPV of 92% independent of other clinical features and would have avoided 26% of unnecessary biopsies while missing only five patients with HGPCa (2.1%). Furthermore, the EPI test provided additional information at a cut-point of 20 and 29.6 with an NPV of 94%, potentially delaying 35% and 61% of unnecessary biopsies, respectively. AUC curves and Net Health Benefit Analyses demonstrated superior performance of ExoDx Prostate over PSA and clinical only risk calculators, i.e. ERSPC.Conclusions: The EPI test provided good performance using the 15.6 cut-point for ruling out HGPCa / GG2 or higher in men undergoing a repeat prostate biopsy with a PSA of 2-10ng/ml. Furthermore, the test utilizes gene expression data independent of clinical features to predict the likelihood of HGPCa / GG2 on a subsequent needle biopsy.

scholarly journals Clinical Performance of the ExoDx (EPI) Prostate Intelliscore Test to Predict High-grade Prostate Cancer at Initial Biopsy: A Pooled Analysis of Three Independent Prospective Studies.

2020 ◽  
Author(s):  
Erik Margolis ◽  
Gordon Brown ◽  
Alan Partin ◽  
Ballentine Carter ◽  
James McKiernan ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Predictive Value ◽  
Validation Studies ◽  
Task Force ◽  
African Ancestry ◽  
Low Grade ◽  
High Grade ◽  
Cut Point ◽  
Non Invasive ◽  
Initial Biopsy

Abstract BACKGROUND The ability to discriminate indolent from clinically significant prostate cancer (PC) in the initial biopsy setting remains an important health issue. ExoDx Prostate(IntelliScore) (EPI), is a non-invasive exosome based liquid biopsy test that quantifies three RNA targets in exosomes from urine. The EPI test is used to help stratify patients for risk of high grade prostate cancer, HGPC (≥ GG2 PC) in men 50 years or older with PSA in the gray zone (2–10 ng/mL). The EPI test has been extensively validated and is included in the NCCN guidelines for prostate cancer early detection. Here we present a pooled meta-analysis from three independent prospective validation studies in men presenting for initial biopsy decision. Age range and PSA level subgroups were also analyzed for EPI performance.METHODS Pooled data from two prospective multi-site validation studies and the control arm of a clinical utility study were analyzed. The data from these three independent trials is presented for men 50 years or older with PSA 2–10 ng/ml presenting for their initial prostate biopsy as well as a subgroup of patients between 55–69 years as recommended by the USPSTF (United States Preventative Services Task Force) and PSA greater than 3 ng/mL as per NCCN 2020 guidelines. Diagnostic needle biopsy outcomes were compared with the EPI score, PSA and both the Prostate Cancer Prevention Trial (PCPT 2.0) and the European Randomized Study of Screening for Prostate Cancer (ERSPC) risk calculators. Performance was evaluated using the area under the receiver operating characteristic curve (AUC), negative predictive value (NPV), positive predictive value (PPV), sensitivity and specificity for discriminating ≥ GG2 from GG1 and benign pathology.RESULTS The combined cohort (n = 1212) of initial biopsy subjects had a median age of 63 years, median PSA 5.2 ng/mL and 17% African ancestry. The positive biopsy rate was 52% for ≥ GG1, 30% ≥GG2 and 14% ≥GG3. The EPI AUC of 0.70 was superior to PSA (AUC:0.56), PCPTRC (AUC: 0.62), and ERSPC (AUC: 0.59), (all p-values < 0.001) for discriminating GG2 from GG1 and benign histology. The previously validated cut-point of 15.6 (or alternative 20) would avoid 23% (or 34%) of all prostate biopsies and 30% (or 43%) of “unnecessary” (benign or Gleason 6/GG1) biopsies, with an NPV of 90% (89%). Across the total cohort (n = 1212), only 2.3% (28/1212) or 3.8% (46/1212) of patients would experience delayed detection of ≥ GG2 at the < 15.6 or < 20 threshold, respectively and for GG3, 1% (12/1212) and 1.5% (19/1212) at either cut-point would be delayed. Comparable results were identified when either the USPSTF 55–69 year age limit or NCCN PSA greater than 3 ng/mL were applied.CONCLUSIONS EPI is a non-invasive, easy to use, urine exosome-RNA assay that has been validated across 3 independent prospective multi-center clinical trials with 1212 patients. The test can discriminate high-grade (≥GG2) from low-grade (GG1) cancer and benign disease and performs equally well in the larger cohort as well as across the USPSTF and NCCN restricted subgroups. EPI effectively guides the biopsy decision process and improves identification of HGPC independent of PSA and other standard of care factors.

scholarly journals Multi-cohort modeling strategies for scalable globally accessible prostate cancer risk tools

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Johanna Tolksdorf ◽  
Michael W. Kattan ◽  
Stephen A. Boorjian ◽  
Stephen J. Freedland ◽  
Karim Saba ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Factors ◽  
Family History ◽  
Cancer Risk ◽  
Risk Prediction ◽  
Prostate Biopsy ◽  
Prostate Cancer Risk ◽  
High Grade ◽  
Prediction Tools ◽  
History Of

Abstract Background Online clinical risk prediction tools built on data from multiple cohorts are increasingly being utilized for contemporary doctor-patient decision-making and validation. This report outlines a comprehensive data science strategy for building such tools with application to the Prostate Biopsy Collaborative Group prostate cancer risk prediction tool. Methods We created models for high-grade prostate cancer risk using six established risk factors. The data comprised 8492 prostate biopsies collected from ten institutions, 2 in Europe and 8 across North America. We calculated area under the receiver operating characteristic curve (AUC) for discrimination, the Hosmer-Lemeshow test statistic (HLS) for calibration and the clinical net benefit at risk threshold 15%. We implemented several internal cross-validation schemes to assess the influence of modeling method and individual cohort on validation performance. Results High-grade disease prevalence ranged from 18% in Zurich (1863 biopsies) to 39% in UT Health San Antonio (899 biopsies). Visualization revealed outliers in terms of risk factors, including San Juan VA (51% abnormal digital rectal exam), Durham VA (63% African American), and Zurich (2.8% family history). Exclusion of any cohort did not significantly affect the AUC or HLS, nor did the choice of prediction model (pooled, random-effects, meta-analysis). Excluding the lowest-prevalence Zurich cohort from training sets did not statistically significantly change the validation metrics for any of the individual cohorts, except for Sunnybrook, where the effect on the AUC was minimal. Therefore the final multivariable logistic model was built by pooling the data from all cohorts using logistic regression. Higher prostate-specific antigen and age, abnormal digital rectal exam, African ancestry and a family history of prostate cancer increased risk of high-grade prostate cancer, while a history of a prior negative prostate biopsy decreased risk (all p-values < 0.004). Conclusions We have outlined a multi-cohort model-building internal validation strategy for developing globally accessible and scalable risk prediction tools.

scholarly journals 1463: Cancer Characteristics in Men Diagnosed with Prostate Cancer Subsequent to Initial Biopsy Showing High Grade Prostatic Intraepithelial Neoplasia

2005 ◽  
Vol 173 (4S) ◽  
pp. 396-397
Author(s):  
Nathan E. Hoffmann ◽  
Thomas J. Sebo ◽  
Diane M. Pierson ◽  
Robert P. Myers ◽  
Michael L. Blute ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Intraepithelial Neoplasia ◽  
Prostatic Intraepithelial Neoplasia ◽  
High Grade ◽  
Initial Biopsy

A gene expression signature to predict high-grade prostate cancer response to oxaliplatin.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 150-150
Author(s):  
Philippe Pourquier ◽  
Stephane Puyo ◽  
Pierre Richaud ◽  
Jacques Robert ◽  
Nadine Houede
Keyword(s):  
Gene Expression ◽  
Prostate Cancer ◽  
Clinical Trials ◽  
Cell Lines ◽  
Gene Expression Signature ◽  
Chemotherapeutic Agents ◽  
Low Grade ◽  
Gleason Grade ◽  
High Grade ◽  
Expression Signature

150 Background: Prostate cancer (PCa) is one of the leading causes of death from cancer in men. High Gleason grade prostate cancers are characterized by aggressive tumors with poorly differentiated cells and a high metastatic potential. They are often refractory to chemical castration but still treated with hormone therapy to which docetaxel or cabazitaxel are added when they become resistant to the anti-androgen. Despite many clinical trials with other chemotherapeutic agents, response rates remain low. Moreover, none of these trials took into account the tumor grade. Methods: We used an in silico approach to screen for drug candidates that could be used as an alternative to taxanes, based on a 86 genes signature which could distinguish between low-grade and high-grade tumors. We extracted from the NCI60 panel databases the expression profiles of the 86 genes across 60 human tumor cell lines and the corresponding in vitro cytotoxicity data of 152 drugs and looked for correlation between their expression level and cell sensitivity to each of these drugs. Results: Among the 86 genes, we identified 9 genes (PCCB, SHMT2, DPM1, RHOT2, RPL13, CD59, EIF4AI, CDKN2C, JUN) for which expression levels across the 60 cell lines was significantly correlated (p< 0.05) to oxaliplatin but not to cisplatin sensitivity. This signature was validated at the functional level since repression of each of these genes conferred a significant change in the sensitivity of PCa cell lines to oxaliplatin but not cisplatin. Conclusions: Our results provide a proof of concept that gene expression signature specific from high grade PCa could be used for the identification of alternative therapies to taxanes. They could also be used to select patients for further clinical trials and as predictive markers of response to these drugs, which represents a further step forward towards personalized therapy of PCa.

A urine exosomal circRNA classifier for detection of high-grade prostate cancer at initial biopsy: A multicenter, retrospective study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5522-5522
Author(s):  
Liaoyuan Li ◽  
Wen Tao ◽  
Yadi He ◽  
Tao He ◽  
Qing Li ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Validation Cohort ◽  
Characteristic Curve ◽  
Specific Antigen ◽  
Digital Rectal Examination ◽  
Circular Rna ◽  
High Grade ◽  
Training Cohort ◽  
Potential Biomarker ◽  
Initial Biopsy

5522 Background: The low specificity of prostate-specific antigen (PSA) has resulted in the overdiagnosis and overtreatment of clinically indolent prostate cancer (PCa). We aimed to identify a urine exosomal circular RNA (circRNA) classifier that could detect high-grade (Gleason score [GS]7 or greater) PCa. Methods: We did a three-stage study that enrolled eligible participants, including PCa-free men, 45 years or older, scheduled for an initial prostate biopsy due to suspicious digital rectal examination findings and/or PSA levels (limit range, 2.0-20.0 ng/mL), from four hospitals in China. We used RNA sequencing and digital droplet polymerase chain reaction to identify 18 candidate urine exosomal circRNAs that were increased in 11 patients with high-grade PCa compared with 11 case-matched patients with benign prostatic hyperplasia. Using a training cohort of eligible participants, we built a urine exosomal circRNA classifier (Ccirc) to detect high-grade PCa. We then evaluated the classifier in discrimination of GS7 or greater from GS6 and benign disease on initial biopsy in two independent cohorts. We used the sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) to evaluate diagnostic performance, and compared Ccirc with standard of care (SOC) (ie, PSA level, age, race, and family history). Results: Between June 1, 2016, and July 31, 2019, we recruited 356 participants to the training cohort, and 442 and 325 participants to the two independent validation cohorts. We identified a Ccirc containing five differentially expressed circRNAs (circ_0049335, circ_0056536, circ_0004028, circ_0008475, and circ_0126027) that could detect high-grade PCa. Ccirc showed higher accuracy than SOC to distinguish individuals with high-grade PCa from controls in both the training cohort and the validation cohorts. (AUC 0.831 [95% CI 0.765-0.883] vs 0.724 [0.705-0.852], P = 0.032 in the training cohort; 0.823 [0.762-0.871] vs 0.706 [0.649-0.762], P = 0.007 in validation cohort 1; and 0.878 [0.802-0.943] vs 0.785 [0.701-0.890], P = 0.021 for validation cohort 2). In all three cohorts, Ccirc had higher sensitivity (range 71.6-87.2%) and specificity (82.3-90.7%) than did SOC (sensitivity, 42.3-68.2%; specificity, 40.1-62.3%) to detect high-grade PCa. Using a predefined cut point, 202 of 767 (26.3%) biopsies would have been avoided, missing only 6% of patients with dominant pattern 4 high-risk GS 7 disease. Conclusions: Ccirc is a potential biomarker for high-grade PCa among suspicious men.

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