Over 50% of patients with systemic LCH are not cured with front-line therapies, and data to guide salvage options are limited. We describe 58 patients with LCH who were treated with clofarabine. Clofarabine monotherapy was active against LCH in this cohort, including heavily pretreated patients with a systemic objective response rate of 92.6%, higher in children (93.8%) than adults (83.3%). BRAFV600E+ variant allele frequency in peripheral blood is correlated with clinical responses. Prospective multicentre trials are warranted to determine optimal dosing, long-term efficacy, late toxicities, relative cost and patient-reported outcomes of clofarabine compared to alternative LCH salvage therapy strategies.

Optimal therapeutic approaches for advanced Langerhans cell histiocytosis (LCH) are not known. We assessed the safety and efficacy of combined chemotherapy with MAPK pathway inhibition in 10 patients with refractory systemic disease and/or LCH-associated neurodegeneration. Overall response rate was 9/10 (90%) for the entire cohort: 5/5 (100%) for patients with systemic disease and 6/7 (86%) for patients with central nervous system disease. BRAFV600E+ peripheral blood fraction decreased in 5/6 (83%). Toxicities included fever, skin rash, myalgias, neuropathy, cytopenias and hypocalcaemia. Prospective trials are required to optimize combination strategies, determine potential to achieve cure and compare outcomes to chemotherapy or MAPK inhibitor monotherapy.

Abstract Purpose: Bacterial species including Cutibacterium acnes (C. acnes) have been associated with different inflammatory and neoplastic conditions in prostate cancer (PCa) tissue samples, but their clinical impact is unknown. Using next-generation sequencing (NGS)–based clinical reports, we investigated the differential abundance and incidence of microbiomes in post–digital rectal exam (DRE) urine samples from patients with PCa and a matched control group at low risk of PCa. Materials and Methods: A total of 200 post-DRE urine samples were analyzed, 100 from patients with histopathologically confirmed PCa and 100 from men at very low risk of PCa with PSA <1.5 ng/mL as controls. Bacterial and fungal communities were characterized by NGS of 16S and internal transcribed spacer (ITS) loci, respectively, with species' relative abundances provided on physicians' clinical reports. The differential abundance and incidence of species between cancer and control groups were evaluated. Results: Microbes were reported in 39% and 56% of PCa and control group samples, respectively. C. acnes had a significantly higher relative abundance in patients with PCa vs controls (P < .05), and C. acnes incidence rates were also nominally higher in patients with PCa as compared with controls (12.82% and 7.27%, respectively). By contrast, Finegoldia magna (F. magna) had a significantly higher relative abundance (P < .05) and incidence rate (P < .05) in controls as compared with patients with PCa. Conclusions: C. acnes was among the most prevalent bacterial species in PCa urine samples. F. magna identified in the low-risk group is responsible for production of equol, a soy metabolite associated with lowering risk of PCa, suggesting a role in prostate cancer chemoprevention.

INTRODUCTION AND OBJECTIVE: Some men are candidates for watchful-waiting (WW) or active surveillance (AS) following TRUS biopsy findings of low-grade prostate cancer (PCa) or benign disease. However, there is an unmet clinical need to reliably rule out high-grade PCa (HGPCa) in these men. The SelectMDx test measures urinary mRNA levels of the homeobox C6 (HOXC6) and distal-less homeobox 1 (DLX1) biomarkers and has been clinically validated for detection of HGPCa upon subsequent TRUS biopsy. We investigated the utility of the SelectMDx test to identify HGPCa in a cohort of men who underwent transperineal mapping biopsy (TPMB) after TRUS biopsy by comparing the SelectMDx results to histopathological findings of TPMB. METHODS: In this retrospective study, 105 patients opted for TPMB to confirm the histopathological findings of their initial TRUS biopsies. Post-DRE, first-void urine specimens were collected from each patient prior to TPMB. SelectMDx testing was performed at MDxHealth, blinded with respect to TPMB outcome. Histopathology of each TPMB was independently read by a genitourinary pathologist. HGPCa was defined as ISUP Grade Group (GG) 2. SelectMDx performance characteristics for detection of HGPCa were determined by comparison to TPMB histopathology data. RESULTS: 29 patients on 5ARI and 8 patients failed SelectMDx test were excluded. The remaining 68 patients were included with median age of 63 (IQR 57-68) years and median PSA 5.1 (3.0-7.6) ng/ mL. TRUS biopsy diagnosed 10 (15%) with benign disease, 37 (54%) patients with GG1, and 21 (31%) with GG2. TPMB identified 12 (18%) patients with benign pathology, 26 (38%) with GG1 PCa, and 30 (44%) with HGPCa (23 GG2, 3 GG3 and 4 GG4). For detection of HGPCa, the SelectMDx test yielded sensitivity of 97% (95% C.I. 83-100%), specificity 37% (22-54%), positive predictive value 55% and negative predictive value (NPV) 93%. The single HGPCa identified in a SelectMDx negative patient was GG2. In a logistic regression analysis including age and PSA, SelectMDx was the only significant predictor of HGPCa at TPMB (b [ 1.09 (p [ 0.0037), odds ratio 2.99, AUC [ 0.738). CONCLUSIONS: The SelectMDx urine test demonstrated high sensitivity and NPV for discriminating between patients with HGPCa vs. patients with GG1 or benign disease at biopsy. These results support the use of SelectMDx to help identify men for WW or AS following TRUS biopsy. Study results also support the use of non-invasive tests to help identify men with HGPCa who may benefit from prostate biopsy, thereby reducing over-detection of indolent disease.

INTRODUCTION:Traditional culture is the current standard-of-care to determine therapeutic antibiotics for patients suffering from penile prostheses (PP) infections. However, approximately 50% of PPs removed for infection are culture negative. Next-generation sequencing (NGS) compares DNA sequences to reference sequences with known microbial taxonomies to identify isolates and report relative abundances. We aim to compare the ability for standard culture and NGS techniques to identify microorganisms and biofilm composition on PPs. MATERIALS AND METHODS:Ninety-one PPs explanted for mechanical malfunction were included in this study. Devices removed for infection or erosion were excluded. During revision surgery, two specimens were collected and sent for culture testing at institutional laboratory and for NGS testing (MicroGenDx, Lubbock, TX, USA). Species' relative abundances, sample diversity and richness, and compositional differences among samples were analyzed. RESULTS:NGS had a higher rate of microbial detection (n = 72, 79.1%) compared to culture results (n = 3, 3.3%). Some of the bacteria identified using both methods were known prosthetic infectious pathogens, with NGS producing more isolates (mean: 11) than culture (mean: 1). Escherichia coli was the most abundant and most frequently occurring bacteria detected on NGS. Coagulase-negative Staphylococci were the most common bacteria detected on traditional culture. CONCLUSIONS:NGS appears to be beneficial in its thorough analysis of PP biofilm composition when compared to culture methods. We hope that further research will be able to demonstrate a clinical benefit of NGS in characterizing distinct microbiomes and biofilms of infected PP, which can aid in tailoring antimicrobial therapy and improving patient outcomes.

You have accessJournal of UrologyInfections/Inflammation/Cystic Disease of the Genitourinary Tract: Kidney & Bladder I (MP25)1 Sep 2021MP25-01 THE URINARY MICROBIOME OF HEALTHY ASYMPTOMATIC MEN AND WOMEN: A REFERENCE FOR INTERPRETATION OF NEXT GENERATION SEQUENCING URINE ANALYSES IN SYMPTOMATIC PATIENTS J. Curtis Nickel, Caleb D. Phillips, Craig D. Tipton, Whitney Stanton, Niccole Diaz, Rick Martin, and E. David Crawford J. Curtis NickelJ. Curtis Nickel More articles by this author , Caleb D. PhillipsCaleb D. Phillips More articles by this author , Craig D. TiptonCraig D. Tipton More articles by this author , Whitney StantonWhitney Stanton More articles by this author , Niccole DiazNiccole Diaz More articles by this author , Rick MartinRick Martin More articles by this author , and E. David CrawfordE. David Crawford More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002022.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The rapid evolution of non-culture technology, such as next generation sequencing (NGS), has led to a surge of patients (and their physicians) submitting midstream urine specimens for NGS analyses. The challenge has been to interpret the comprehensive microbiota data generated by this state-of-the-art technology. We sought to describe the normal urinary microbiome of healthy men and women without urinary disease so that we can better utilize NGS microbiome reports of patients with symptoms. METHODS: Asymptomatic subjects with no recent UTI, antibiotic use within 2 weeks or history of bladder pain were invited to provide demographic data and midstream urine specimen for urinalysis (excluded if positive) and NGS analysis (MicroGenDX). Independent and interaction effects of sample factors (e.g. gender, age, diet, menopausal status) on microbiome composition, abundance and diversity was assessed. RESULTS: NGS data was available for 106 female and 105 male subjects (median age 39). The taxonomic classification of observed bacterial lineages included 643 species (307 genera) with largest number of species detected in Proteobacteria, Firmicutes, Actinobacteria and Bacteroidetes phylum (Figure). Gender and antibiotic use within the past 3 months were associated with differential alpha (within sample) diversity. However, the relationship between alpha diversity and age was not significant. Compositional differences in microbiome among samples (beta diversity) was explained by gender and age with gender being the most influential. Gender was also identified as the variable that significantly explained differences in species abundance, while diet and menopausal status were not significant factors. Considering both genders led to identification of two community state types (CST1,2), with most males included in CST1 while females were classified into both. Further investigation within gender suggested 3 female CSTs, one of which was comprised of significantly younger participants. CONCLUSIONS: Interpretation of NGS analyses of urine specimens for possible bacterial infection as a cause for bladder symptoms and pain will need to consider the differential impact of gender, and to a lesser extent, age, and previous antibiotic use. Source of Funding: MicroGenDX © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e453-e453 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information J. Curtis Nickel More articles by this author Caleb D. Phillips More articles by this author Craig D. Tipton More articles by this author Whitney Stanton More articles by this author Niccole Diaz More articles by this author Rick Martin More articles by this author E. David Crawford More articles by this author Expand All Advertisement PDF downloadLoading ...

You have accessJournal of UrologyProstate Cancer: Detection & Screening VI (PD56)1 Sep 2021PD56-09 MICROBIOMES IN POST-DIGITAL RECTAL EXAM URINE SAMPLES ARE LINKED TO PROSTATE CANCER RISK E David Crawford, Whitney N Stanton, Rick Martin, Caleb D Phillips, Adrie van Bokhoven, M Scott Lucia, Paul Arangua, Francisco G La Rosa, Zachary Grasmick, Gretchen Hoyer, Nelson N Stone, Ryan Terlecki, J Curtis Nickel, and Priya N Werahera E David CrawfordE David Crawford More articles by this author , Whitney N StantonWhitney N Stanton More articles by this author , Rick MartinRick Martin More articles by this author , Caleb D PhillipsCaleb D Phillips More articles by this author , Adrie van BokhovenAdrie van Bokhoven More articles by this author , M Scott LuciaM Scott Lucia More articles by this author , Paul AranguaPaul Arangua More articles by this author , Francisco G La RosaFrancisco G La Rosa More articles by this author , Zachary GrasmickZachary Grasmick More articles by this author , Gretchen HoyerGretchen Hoyer More articles by this author , Nelson N StoneNelson N Stone More articles by this author , Ryan TerleckiRyan Terlecki More articles by this author , J Curtis NickelJ Curtis Nickel More articles by this author , and Priya N WeraheraPriya N Werahera More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002090.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We investigated the microbiome of post-digital rectal exam (DRE) urine specimens from prostate cancer (PCa) patients and a screening population with a PSA <1.5 ng/mL using PCR (polymerase chain reaction) and next generation sequencing (NGS) techniques. METHODS: 100 post-DRE urine specimens from patients with PCa were compared to 100 specimens from annual Prostate Cancer Awareness Week participants with PSA <1.5 ng/mL (low risk group). Microbial PCR and NGS was performed by MicroGenDX. RESULTS: Analysis of microbiome composition by NGS identified Cutibacterium acnes as significantly more abundant in PCa compared to low risk controls (P < 0. 05) (difference more pronounced in high grade PCa. Finegoldia magna was significantly more abundant in low risk controls (P < 0.05) compared to PCa. PCR differentially identified Klebsiella pneumoniae, Gardnerella vaginalis, Prevotella bivia, and Ureaplasma parvum, in PCa group. PCR detected Escherichia coli, Prevotella bivia, Mycoplasma hominis, Gardnerella vaginalis, and Ureaplasma parvum in the low risk control group. CONCLUSIONS: PCR and NGS analysis of post-DRE urinary microbiome showed detection and abundance differences in PCa compared to low risk controls. Cutibacterium acnes strain Type II identified in PCa in our study has been reported as the most prevalent bacterial species in PCa tissue samples. The presence of Finegoldia magna differentially identified in the group with a low risk of PCa is responsible for the production of equol, a soy metabolite associated with lowering risk of cancer. Our observations indicate the need for corroborative urine, tissue, and semen microbiome studies to identify a possible microbial contribution to prostate cancer risk. Source of Funding: Supported in parts by Schramm Foundation, Bingham Foundation, and Prostate Cancer Biorepository at the University of Colorado Anschutz Medical Campus © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1007-e1007 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information E David Crawford More articles by this author Whitney N Stanton More articles by this author Rick Martin More articles by this author Caleb D Phillips More articles by this author Adrie van Bokhoven More articles by this author M Scott Lucia More articles by this author Paul Arangua More articles by this author Francisco G La Rosa More articles by this author Zachary Grasmick More articles by this author Gretchen Hoyer More articles by this author Nelson N Stone More articles by this author Ryan Terlecki More articles by this author J Curtis Nickel More articles by this author Priya N Werahera More articles by this author Expand All Advertisement PDF downloadLoading ...

Introduction: To identify patients at risk of high-grade prostate cancer using prostate cancer biomarkers. Materials and methods: A total of 601 men were screened for prostate cancer in 2012, 2015, and 2016 using prostate cancer biomarkers: prostate health index (phi), 4KScore, and SelectMDx. The first two are blood tests that incorporate several PSA isoforms; SelectMDx measures mRNA levels of homeobox C6 and distal-less homeobox 1 in post-digital rectal examination urine samples. The performance of each biomarker was evaluated using cut off values based on published literature. Gleason Grade Group (GG) >= 2 is considered as high-grade prostate cancer. Results: For patients with PSA < 1.5 ng/mL, none were at risk for GG >= 2 cancer based on SelectMDx > 0%, whereas 17.1% were at intermediate to high risk of finding GG >= 2 cancer with 4KScore >= 7.5%, and 3.5% were at risk offinding any prostate cancer with phi >= 36 at biopsy. For cut offs revised for finding men at high risk for GG >= 2 cancer at biopsy, only one patient with PSA < 1.5 ng/mL would be at risk with 4KScore >= 20% and none with phi >= 52.7. For patients with PSA 1.5 to 3.99 ng/mL, 2%, 8%, and 1% were at high risk for finding GG >= 2 cancer at biopsy based on phi, 4KScore, and SelectMDx, respectively. Conclusions: Men with PSA < 1.5 ng/mL are at very low risk of finding high-grade prostate cancer at biopsy. However, some men with PSA between 1.5 to 3.99 ng/mL may be at intermediate to high risk for high-grade prostate cancer. Thus, primary care physicians could run biomarkers test and refer those with positive biomarker results to a specialist for further evaluation.

Previous studies have used traditional culture methods to identify microbial biofilm composition present at removal and replacement of penile prostheses. Next generation sequencing of DNA, which is then compared to known bacterial and fungal taxonomies to identify isolates and microbial susceptibilities and is considered the gold standard in other medical specialties. The purpose of this study was to compare biofilm compositions and antimicrobial sensitivities/resistances at penile prosthesis removal/replacement using next generation DNA sequencing to traditional culture methods. 2 intraoperative penile prosthesis pump fluid /capsule specimens were submitted at the time of revision surgery: one for each traditional culture and next-generation sequencing. For the next-generation DNA sequencing methods, the pathogens’ genetic signatures and the estimated percentages of organisms present in each specimen with any biofilm pathogens evaluated against 34 unique antimicrobial agents. 44 patients had both traditional and next generation sequencing results to compare. Some of the bacteria identified using both methods were known prosthetic infectious pathogens with the next generation DNA sequencing producing more isolates than traditional culture methods (p <0.05). All next generation sequencing isolates had sensitivities/resistances to 34 unique antimicrobial agents, enabling the physician to accurately tailor treatments for each patient and was significantly highly number of unique antimicrobial agents than traditional culture methods 7.3 (p < 0.01).

E David Crawford Whitney Stanton 2 Divneet Mandair 1Department of Urology, University of California at San Diego, La Jolla, CA, USA; 2Department of Pathology, University of Colorado School of Medicine, Aurora, CO, USA; 3Division of Internal Medicine, University of Colorado School of Medicine, Aurora, CO, USA Abstract: Men treated with androgen deprivation therapy for rising PSA after failed local therapy will often develop castrate resistance, and the appearance of metastases predicts a poor prognosis. Thus, researchers have long sought to prolong the onset of metastasis in patients with nonmetastatic castration-resistant prostate cancer (CRPC). Until 2018, patients in this group had no FDA-approved treatment options. They were typically managed with androgen-deprivation therapy (ADT) to maintain castrate systemic testosterone levels and given approved therapies for metastatic CRPC once metastases appeared. However, third-generation androgen receptor inhibitors (ARIs) have dramatically changed the treatment paradigm, having shown the ability to extend metastasis-free survival (MFS) significantly over ADTalone in Phase 3 trials. The newest of these, darolutamide, prolonged MFS 22 months over placebo while also improving a host of secondary and exploratory endpoints such as overall survival (OS), prostate-specific antigen (PSA) progression and time to pain progression, chemotherapy initiation, and symptomatic skeletal events. Among third-generation ARIs, darolutamide is unique in that it incorporates two pharmacologically active diastereomers and has demonstrated resistance to all known androgen receptor (AR) mutations. Additionally, patients taking darolutamide appear to experience comparatively few central nervous system-related adverse events (AEs) such as fatigue and falls, and no increases in seizures have been reported in the drug’s clinical or preclinical development. Various authors attribute the low incidence of CNS-related AEs to darolutamide’s minimal penetration of the blood–brain barrier (BBB). Other side effects ranging from hot flashes to hypothyroidism also occurred at rates similar to those of the placebo arm in Phase 3. As ADT in itself raises cardiovascular risk, the cardiovascular safety of third-generation antiandrogens as a category warrants continued scrutiny. In total, however, published data suggest that darolutamide provides a reasonable option for patients with nonmetastatic CRPC. Ongoing research will determine darolutamide’s potential role in additional disease states such as localized and castration-sensitive PCa.

Men treated with androgen deprivation therapy for rising PSA after failed local therapy will often develop castrate resistance, and the appearance of metastases predicts a poor prognosis. Thus, researchers have long sought to prolong the onset of metastasis in patients with nonmetastatic castration-resistant prostate cancer (CRPC). Until 2018, patients in this group had no FDA-approved treatment options. They were typically managed with androgen-deprivation therapy (ADT) to maintain castrate systemic testosterone levels and given approved therapies for metastatic CRPC once metastases appeared. However, third-generation androgen receptor inhibitors (ARIs) have dramatically changed the treatment paradigm, having shown the ability to extend metastasis-free survival (MFS) significantly over ADT alone in Phase 3 trials. The newest of these, darolutamide, prolonged MFS 22 months over placebo while also improving a host of secondary and exploratory endpoints such as overall survival (OS), prostate-specific antigen (PSA) progression and time to pain progression, chemotherapy initiation, and symptomatic skeletal events. Among third-generation ARIs, darolutamide is unique in that it incorporates two pharmacologically active diastereomers and has demonstrated resistance to all known androgen receptor (AR) mutations. Additionally, patients taking darolutamide appear to experience comparatively few central nervous system-related adverse events (AEs) such as fatigue and falls, and no increases in seizures have been reported in the drug's clinical or preclinical development. Various authors attribute the low incidence of CNS-related AEs to darolutamide's minimal penetration of the blood-brain barrier (BBB). Other side effects ranging from hot flashes to hypothyroidism also occurred at rates similar to those of the placebo arm in Phase 3. As ADT in itself raises cardiovascular risk, the cardiovascular safety of third-generation antiandrogens as a category warrants continued scrutiny. In total, however, published data suggest that darolutamide provides a reasonable option for patients with nonmetastatic CRPC. Ongoing research will determine darolutamide's potential role in additional disease states such as localized and castration-sensitive PCa.

30 Background: A major clinical challenge is to identify patients at increased risk of high-grade prostate cancer (PCa) (Gleason scores ≥ 7) before biopsy. Thus, we evaluated the clinical utility of SelectMDx and Prostate Health Index (phi) tests for diagnosis of high-grade PCa as compared with transperineal mapping biopsy (TMB) results, where an average of 80 prostate needle biopsies are taken every 5 mm for a diagnostic accuracy of 98%. Methods: 70 patients were selected who had TMB. They were evaluated with both SelectMDx and phi tests from before or after TMB; all had serum and post-digital rectal examination urine samples collected prior to treatment, stored in our biorepository. phi was evaluated using proPSA, free PSA and total PSA in serum. SelectMDx test measured mRNA levels of the HOXC6 and DLX1 in post-DRE urine. Published data shows that phi <27 and SelectMDx score = 0% correlate with patients free of HG PCa. Test results were compared against TMB histopathology data. Multivariate logistic regression (MLS) analyses and receiver operating characteristic (ROC) curves were used to determine diagnostic accuracy. DeLong test was used to determine statistical significance of ROC curves. All analyses were done for diagnosis of any PCa and high-grade PCa. Results: TMB histopathology showed 17/70 patients with no PCa and 22/53 with high-grade PCa. The sensitivity, specificity, positive (PPV) and negative (NPV) predictive values of each test are shown in the table below. Pairwise ROC comparison showed no statistically significant difference in the area under the curve of diagnosing PCa (0.75 vs 0.65) and high-grade PCa (0.71 vs 0.81) by phi and SelectMDx tests respectively. MLS analyses showed phi was significantly better than SelectMDx for diagnosing PCa (β = 0.054; p=0.005) and SelectMDx was significantly better than phi for diagnosing high-grade PCa (β = 8.45; p=0.0002). Conclusions: With high sensitivity and NPV, SelectMDx test is more useful than phi for screening patients at risk of high-grade PCa prior to biopsy. [Table: see text]

We describe our experience with four patients undergoing cryotherapy for treatment of prostate cancer. Micro-ultrasound was utilized in conjunction with standard transrectal ultrasound to intraoperatively assess lesions. In addition, the results were compared to preoperative mpMRI in several patients. The use of micro-ultrasound has been evaluated in clinical trials to include real-time imaging in the clinic for biopsies and fusion with prior mpMRI. We evaluated the technique in men with known prostate cancer undergoing cryoablation. Micro-ultrasound has the potential to replace the current clinical methods for targeted prostate biopsies and improve intraoperative monitoring.

64 Background: Prostate Specific Antigen (PSA) screening remains controversial primarily because of over detection and treatment. There is an unmet clinical need to identify patients at increased risk for high-grade (HG – Gleason Score ≥7) prostate cancer (PCa) since PSA has low sensitivity. Combining PSA with well-validated prostate cancer biomarkers (PCM) can improve risk assessment. We investigated the performance of three PCMs (phi – prostate health index, 4KScore, and SelectMDx) on patients with PSA levels < 1.5 ng/mL that represent a “safe zone” where risk of any PCa is rare Methods: 652 men were screened for PCa during the annual Prostate Cancer Awareness Week at the University of Colorado Hospital. This study was supported by Prostate Condition Education Council and the Schramm Foundation. phi is evaluated using p2PSA, total PSA, and free PSA in serum. Phi < 52.7 suggests absence of HG PCa. 4KScore incorporates four kallikrein protein biomarkers: total PSA, free PSA, intact PSA, human kallikrein protein, and clinical information. A 4KScore < 20% suggests absence of HG PCa. The SelectMDx post-DRE urine test measures mRNA levels of the homeobox C6 and distal-less homeobox 1 biomarkers. SelectMDx score of 0% indicates absence of HG PCa. Results: No patients with a PSA < 1.5 had SelectMDx > 0% and/or phi > 52.7. One patient had a 4KScore of 27%, indicating a risk for HG PCa. For patients with PSA between 1.5-3.99, 2.9% (4/135), 7.4% (4/54), and 2.3% (2/85) had positive phi, 4KScore, and SelectMDx results, respectively. Conclusions: Men with PSA <1.5 ng/mL are at very low risk for HG PCa. Men with PSA between 1.5-3.99 with positive PCM results may be referred for further evaluation. [Table: see text]