scholarly journals Optimized Identification of High-Grade Prostate Cancer by Combining Different PSA Molecular Forms and PSA Density in a Deep Learning Model

Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 335
Author(s):  
Francesco Gentile ◽  
Matteo Ferro ◽  
Bartolomeo Della Ventura ◽  
Evelina La Civita ◽  
Antonietta Liotti ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prostate Biopsy ◽  
Specific Antigen ◽  
Molecular Forms ◽  
Psa Density ◽  
Prostate Specific Antigen Test ◽  
Free Psa ◽  
Artificial Neuronal Networks ◽  
Total Psa ◽  
Deep Learning Model

After skin cancer, prostate cancer (PC) is the most common cancer among men. The gold standard for PC diagnosis is based on the PSA (prostate-specific antigen) test. Based on this preliminary screening, the physician decides whether to proceed with further tests, typically prostate biopsy, to confirm cancer and evaluate its aggressiveness. Nevertheless, the specificity of the PSA test is suboptimal and, as a result, about 75% of men who undergo a prostate biopsy do not have cancer even if they have elevated PSA levels. Overdiagnosis leads to unnecessary overtreatment of prostate cancer with undesirable side effects, such as incontinence, erectile dysfunction, infections, and pain. Here, we used artificial neuronal networks to develop models that can diagnose PC efficiently. The model receives as an input a panel of 4 clinical variables (total PSA, free PSA, p2PSA, and PSA density) plus age. The output of the model is an estimate of the Gleason score of the patient. After training on a dataset of 190 samples and optimization of the variables, the model achieved values of sensitivity as high as 86% and 89% specificity. The efficiency of the method can be improved even further by training the model on larger datasets.

Discordant prostate specific antigen test results despite WHO assay standardization

2018 ◽  
Vol 33 (3) ◽  
pp. 275-282 ◽  
Author(s):  
Martin Boegemann ◽  
Christian Arsov ◽  
Boris Hadaschik ◽  
Kathleen Herkommer ◽  
Florian Imkamp ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Early Detection ◽  
Specific Antigen ◽  
Test Results ◽  
Serum Samples ◽  
Prostate Specific Antigen Test ◽  
Free Psa ◽  
Prostate Biopsies ◽  
Cancer Early Detection ◽  
Total Psa

Introduction: Total PSA (tPSA) and free PSA (fPSA) are the most commonly used biomarkers for early detection of prostate cancer. Despite standardization efforts, many available PSA assays may still produce discordant results. In the present study, we compared four PSA assays calibrated to the WHO standards 96/670 and 96/668 for tPSA and fPSA, respectively. Methods: Within the scope of the Prostate Cancer Early Detection Study Based on a ‘‘Baseline’’ PSA Value in Young Men (PROBASE), we tested tPSA and fPSA in serum samples from 50 patients in the four different PROBASE sites using four WHO-calibrated assays from Roche (Elecsys, Cobas), Beckman-Coulter (Access-II) and Siemens (ADVIA Centaur). The comparison was performed using the Passing–Bablok regression method. Results: Compared to Access, the median tPSA levels for Centaur, Elecsys, and Cobas were +3%, +11%–20%, and +17%–23%, respectively, while for median fPSA levels the differences for Centaur, Elecsys, and Cobas were +49%, +29%–31%, and +22%, respectively. Discussion: Despite all investigated assays being WHO-calibrated, the Elecsys and Cobas tPSA assays produced considerably higher results than the Access and Centaur assays. Differences in fPSA-recovery between all investigated assays were even more pronounced. When applying the tPSA cutoff of 3.1 μg/L recommended for WHO-calibrated assays, the use of higher calibrated assays may lead to unnecessary prostate biopsies. Conversely, if the historical threshold of 4 μg/L is applied when using WHO-calibrated assays, it could lead to falsely omitted prostate biopsies.

Novel Artificial Neural Network for Early Detection of Prostate Cancer

2002 ◽  
Vol 20 (4) ◽  
pp. 921-929 ◽  
Author(s):  
Bob Djavan ◽  
Mesut Remzi ◽  
Alexandre Zlotta ◽  
Christian Seitz ◽  
Peter Snow ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Early Detection ◽  
Roc Curve ◽  
Predictive Accuracy ◽  
Specific Antigen ◽  
Psa Density ◽  
Free Psa ◽  
Ann Models ◽  
Artificial Neural ◽  
Total Psa

PURPOSE: Two artificial neural networks (ANN) for the early detection of prostate cancer in men with total prostate-specific antigen (PSA) levels from 2.5 to 4 ng/mL and from 4 to 10 ng/mL were prospectively developed. The predictive accuracy of the ANN was compared with that obtained by use of conventional statistical analysis of standard PSA parameters. PATIENTS AND METHODS: Consecutive men with a serum total PSA level between 4 and 10 ng/mL (n = 974) and between 2.5 and 4 ng/mL (n = 272) were analyzed. A separate ANN model was developed for each group of patients. Analyses were performed to determine the presence of prostate cancer. RESULTS: The area under the receiver operator characteristic (ROC) curve (AUC) was 87.6% and 91.3% for the 2.5 to 4 ng/mL and 4 to 10 ng/mL ANN models, respectively. For the latter model, the AUC generated by the ANN was significantly higher than that produced by the single variables of total PSA, percentage of free PSA, PSA density of the transition zone (TZ), and TZ volume (P < .01), but not significantly higher compared with multivariate analysis. For the 2.5 to 4 ng/mL model, the AUC of the ANN ROC curve was significantly higher than the AUCs for percentage of free PSA (P = .0239), PSA-TZ (P = .0204), and PSA density and total prostate volume (P < .01 for both). CONCLUSION: The predictive accuracy of the ANN was superior to that of conventional PSA parameters. ANN models might change the way patients referred for early prostate cancer detection are counseled regarding the need for prostate biopsy.

scholarly journals Value of MRI to Improve Deep Learning Model That Identifies High-Grade Prostate Cancer. Comment on Gentile et al. Optimized Identification of High-Grade Prostate Cancer by Combining Different PSA Molecular Forms and PSA Density in a Deep Learning Model. Diagnostics 2021, 11, 335

Diagnostics ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 1213
Author(s):  
Joshua S. Jue ◽  
David Mikhail ◽  
Javier González ◽  
Mahmoud Alameddine
Keyword(s):  
Prostate Cancer ◽  
Deep Learning ◽  
Specific Antigen ◽  
Learning Model ◽  
Molecular Forms ◽  
Model Diagnostics ◽  
High Grade ◽  
Resonance Imaging ◽  
Psa Density ◽  
Deep Learning Model

Prostate-specific antigen (PSA) has been criticized for its low specificity for prostate cancer, which has led to the increased adoption of additional biomarkers, PSA density (PSAD), and multiparametric magnetic resonance imaging (mpMRI) to increase the localization, risk stratification, and diagnosis of prostate cancer [...]

Serum Human Glandular Kallikrein-2 Protease Levels Predict the Presence of Prostate Cancer Among Men With Elevated Prostate-Specific Antigen

2000 ◽  
Vol 18 (5) ◽  
pp. 1036-1036 ◽  
Author(s):  
Robert K. Nam ◽  
Eleftherios P. Diamandis ◽  
Ants Toi ◽  
John Trachtenberg ◽  
Angeliki Magklara ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Detection ◽  
Prostate Biopsy ◽  
Odds Ratio ◽  
Specific Antigen ◽  
Prostate Cancer Detection ◽  
Free Psa ◽  
Glandular Kallikrein ◽  
Kallikrein 2 ◽  
Total Psa

PURPOSE: We hypothesize that serum human glandular kallikrein-2 (hK2) levels predict the presence of prostate cancer among men prescreened by prostate-specific antigen (PSA).PATIENTS AND METHODS: We conducted a cross-sectional study of 324 men who had no history of prostate cancer and who were referred for prostate biopsy. PSA and hK2 levels were measured using specific nonisotopic immunometric techniques. Cases were patients who were diagnosed with adenocarcinoma of the prostate from biopsy, and controls were patients who had no evidence of cancer from biopsy. The odds ratio for detection of prostate cancer was determined for hK2 measurements, controlling for age, total-PSA level, digital rectal examination, and symptoms of urinary obstruction.RESULTS: Of 324 men, 159 (49.1%) had cancer. Mean hK2 levels and hK2:free-PSA ratios were significantly higher in cases than in controls (1.18 v 0.53 ng/mL, respectively, for hK2, P = .0001; 1.17 v 0.62 for hK2:free-PSA ratio, P = .0001). The crude odds ratio for prostate cancer detection for patients in the highest quartile of hK2 level was 5.83 (95% confidence interval [CI], 2.8 to 12.1; P = .0001) compared with patients in the lowest quartile. The adjusted odds ratio was 6.72 (95% CI, 2.9 to 15.6; P = .0001). Similarly, the crude and adjusted odds ratios for prostate cancer detection using the hK2:free-PSA ratio were 7.36 (95% CI, 3.6 to 15.1; P = .0001) and 8.06 (95% CI, 3.7 to 17.4; P = .0001), respectively. These odds ratios were higher than that observed for prostate cancer detection by total-PSA level (2.73; P = .03).CONCLUSION: Among men prescreened with PSA for prostate cancer, patients with high hK2 measurements have a five- to eight-fold increase in risk for prostate cancer, adjusting for PSA level and other established risk factors. hK2 measurements may be a useful adjunct to PSA in improving patient selection for prostate biopsy.

scholarly journals CAN PROSTATE-SPECIFIC ANTIGEN DENSITY AND FREE / TOTAL PROSTATE-SPECIFIC ANTIGEN RATIO PREDICT CLINICALLY SIGNIFICANT PROSTATE CANCER (GLEASON ≥ 7) IN PATİENTS DIAGNOSED PROSTATE CANCER ON BIOPSY WITH A PROSTATE-SPECIFIC ANTIGEN LEVEL OF 2.5 -10 NG/ML?

2021 ◽  
Author(s):  
Fatih Bicaklioglu ◽  
Hasan Aydin ◽  
Ahmet Özgür Güçtaş ◽  
Hamit Zafer Aksoy
Keyword(s):  
Prostate Cancer ◽  
Prostate Specific Antigen ◽  
Sensitivity And Specificity ◽  
Prostate Biopsy ◽  
Specific Antigen ◽  
Free Psa ◽  
Total Prostate Specific Antigen ◽  
Prostate Specific Antigen Density ◽  
Clinically Significant ◽  
Total Psa

Introduction Many men with non-clinically significant PCa (N-CSPCa) will not progress to become symptomatic within their lifetime. If we can predict clinically significant PCa (CSPCa), we can prevent patients from unnecessary biopsies, overdiagnoses, and overtreatment. The purpose of this study was to determine whether PSAD and f/t PSA can predict CSPCa (Gleason ≥ 7) in patients diagnosed with prostate cancer on biopsy with a PSA level of 2.5-10 ng/ml or not. Materials and Methods 78 patients who underwent TRUSG-guided prostate biopsy with PSA 2.5-10.0 in our clinic between March 2017 - August 2020 and whose pathology result was reported as prostate adenocarcinoma, were retrospectively evaluated. In addition to the demographic content of the patients, PSA, free PSA, prostate size (with TRUSG), rectal examination findings and prostate biopsy pathology results were recorded. Clinically significant prostate cancer was defined as a Gleason score 7. Results The mean age of the patients was 66.9 ± 8.4, PSA value was 6.9 ± 1.8, free / total PSA ratio was 18 ± 8.1%, and PSA density was 0.150 ± 0.078. The P values of PSA, free PSA, PSAD, f/t PSA, and prostate volume between CSPCa and N- CSPCa groups were 0.010, 0.780, 0.001, 0.084, and 0.030, respectively. The area under the ROC curve (AUC) of the PSAD for predicting CSPCa was 0.719 with a 95% Cl (0.604–0.835), and the standard errors were 0.062 and 0.059, respectively. When PSAD cutoff was 0.130 for predicting CSPCa, sensitivity and specificity were 75% and 63%, respectively. Conclusion PSAD can be used for predicting CSPCa, but f/t PSA can not. PSAD is not a strong stand-alone tool with its sensitivity and specificity, but we suggest that PSAD can be a part of future nomograms for predicting CSPCa and future protocols for active surveillance. Key words:prostate-specific antigen; clinically significant prostate cancer

scholarly journals Integrated predictive model for prostatic cancer using clinical, laboratory and ultrasound data

2016 ◽  
Vol 43 (6) ◽  
pp. 430-437
Author(s):  
GUSTAVO DAVID LUDWIG ◽  
HENRIQUE PERES ROCHA ◽  
LÚCIO JOSÉ BOTELHO ◽  
MAIARA BRUSCO FREITAS
Keyword(s):  
Prostate Cancer ◽  
Predictive Model ◽  
Prostate Biopsy ◽  
Clinical Laboratory ◽  
Prostate Volume ◽  
Specific Antigen ◽  
Digital Rectal Examination ◽  
Roc Curves ◽  
Rectal Examination ◽  
Psa Density

ABSTRACT Objective: to develop a predictive model to estimate the probability of prostate cancer prior to biopsy. Methods: from September 2009 to January 2014, 445 men underwent prostate biopsy in a radiology service. We excluded from the study patients with diseases that could compromise the data analysis, who had undergone prostatic resection or used 5-alpha-reductase inhibitors. Thus, we selected 412 patients. Variables included in the model were age, prostate specific antigen (PSA), digital rectal examination, prostate volume and abnormal sonographic findings. We constructed Receiver Operating Characteristic (ROC) curves and calculated the areas under the curve, as well as the model's Positive Predictive Value (PPV) . Results: of the 412 men, 155 (37.62%) had prostate cancer (PC). The mean age was 63.8 years and the median PSA was 7.22ng/ml. In addition, 21.6% and 20.6% of patients had abnormalities on digital rectal examination and image suggestive of cancer by ultrasound, respectively. The median prostate volume and PSA density were 45.15cm3 and 0.15ng/ml/cm3, respectively. Univariate and multivariate analyses showed that only five studied risk factors are predictors of PC in the study (p<0.05). The PSA density was excluded from the model (p=0.314). The area under the ROC curve for PC prediction was 0.86. The PPV was 48.08% for 95%sensitivity and 52.37% for 90% sensitivity. Conclusion: the results indicate that clinical, laboratory and ultrasound data, besides easily obtained, can better stratify the risk of patients undergoing prostate biopsy.

scholarly journals Usefulness of the prostate health index in predicting the presence and aggressiveness of prostate cancer among Korean men: a prospective observational study

BMC Urology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jae Yoon Kim ◽  
Ji Hyeong Yu ◽  
Luck Hee Sung ◽  
Dae Yeon Cho ◽  
Hyun-Jung Kim ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Observational Study ◽  
Prospective Observational Study ◽  
Specific Antigen ◽  
Significant Proportion ◽  
Health Index ◽  
Free Psa ◽  
Prostate Health Index ◽  
Total Psa ◽  
Prostate Health

Abstract Background We aimed to evaluate the usefulness of the Beckman Coulter prostate health index (PHI) and to compare it with total prostate-specific antigen (PSA) levels and related derivatives in predicting the presence and aggressiveness of prostate cancer (PCa) in the Korean population. Methods A total of 140 men who underwent their first prostate biopsy for suspected PCa were included in this prospective observational study. The diagnostic performance of total PSA, free PSA, %free PSA, [–2] proPSA (p2PSA), %p2PSA, and PHI in detecting and predicting the aggressiveness of PCa was estimated using the receiver operating characteristic curve (ROC) and logistic multivariate regression analyses. Results Of 140 patients, PCa was detected in 63 (45%) of participants, and 48 (76.2%) of them had significant cancer with a Gleason score (GS) ≥ 7. In the whole group, the area under the curve (AUC) for ROC analysis of tPSA, free PSA, %fPSA, p2PSA, %p2PSA, and PHI were 0.63, 0.57, 0.69, 0.69, 0.72, and 0.76, respectively, and the AUC was significantly greater in the PHI group than in the tPSA group (p = 0.005). For PCa with GS ≥ 7, the AUCs for tPSA, free PSA, %fPSA, p2PSA, %p2PSA, and PHI were 0.62, 0.58, 0.41, 0.79, 0.86, and 0.87, respectively, and the AUC was significantly greater in the PHI group than in the tPSA group (p < 0.001). In the subgroup with tPSA 4–10 ng/mL, both %p2PSA and PHI were strong independent predictors for PCa (p = 0.007, p = 0.006) and significantly improved the predictive accuracy of a base multivariable model, including age, tPSA, fPSA and %fPSA, using multivariate logistic regression analysis. (p = 0.054, p = 0.048). Additionally, at a cutoff PHI value > 33.4, 22.9% (32/140) of biopsies could be avoided without missing any cases of aggressive cancer. Conclusions This study shows that %p2PSA and PHI are superior to total PSA and %fPSA in predicting the presence and aggressiveness (GS ≥ 7) of PCa among Korean men. Using PHI, a significant proportion of unnecessary biopsies can be avoided.

scholarly journals The Combination of Human Glandular Kallikrein and Free Prostate-specific Antigen (PSA) Enhances Discrimination Between Prostate Cancer and Benign Prostatic Hyperplasia in Patients with Moderately Increased Total PSA

1999 ◽  
Vol 45 (11) ◽  
pp. 1960-1966 ◽  
Author(s):  
Angeliki Magklara ◽  
Andreas Scorilas ◽  
William J Catalona ◽  
Eleftherios P Diamandis
Keyword(s):  
Prostate Cancer ◽  
Benign Prostatic Hyperplasia ◽  
Prostate Specific Antigen ◽  
Prostatic Carcinoma ◽  
Specific Antigen ◽  
Area Under The Curve ◽  
Prostatic Hyperplasia ◽  
Free Psa ◽  
Glandular Kallikrein ◽  
Total Psa

Abstract Background: Prostate-specific antigen (PSA) is the most reliable tumor marker available and is widely used for the diagnosis and management of prostate cancer. Unfortunately, PSA cannot distinguish efficiently between benign and malignant disease of the prostate, especially within the range of 4–10 μg/L. Among the refinements developed to enhance PSA specificity is the free/total PSA ratio, which is useful in discriminating between the two diseases within the diagnostic “gray zone”. Recent data indicate that human glandular kallikrein (hK2), a protein with high homology to PSA, may be an additional serum marker for the diagnosis and monitoring of prostate cancer. Methods: We analyzed 206 serum samples (all before treatment was initiated) from men with histologically confirmed benign prostatic hyperplasia (n = 100) or prostatic carcinoma (n = 106) with total PSA in the range of 2.5–10 μg/L. Total and free PSA and hK2 were measured with noncompetitive immunological procedures. Statistical analysis was performed to investigate the potential utility of the various markers or their combinations in discriminating between benign prostatic hyperplasia and prostatic carcinoma. Results: hK2 concentrations were not statistically different between the two groups of patients. There was a strong positive correlation between hK2 and free PSA in the whole patient population. hK2/free PSA ratio (area under the curve = 0.69) was stronger predictor of prostate cancer than the free/total PSA ratio (area under the curve = 0.64). At 95% specificity, the hK2/free PSA ratio identified 30% of patients with total PSA between 2.5–10 μg/L who had cancer. At 95% specificity, the hK2/free PSA ratio identified 25% of patients with total PSA between 2.5 and 4.5 μg/L who had cancer. Conclusions: Our data suggest that hK2 in combination with free and total PSA can enhance the biochemical detection of prostate cancer in patients with moderately increased total PSA concentrations. More specifically, the hK2/free PSA ratio appears to be valuable in identifying a subset of patients with total PSA between 2.5 and 4.5 μg/L who have high probability of cancer and who should be considered for biopsy.

The Association of PSA-IGM and Total PSA Improves the Diagnosis of Prostate Cancer

2009 ◽  
Vol 24 (3) ◽  
pp. 212-212
Author(s):  
Danilo Zani ◽  
Silvia Costa ◽  
Lorenzo Gatti ◽  
Nicola Pesenti ◽  
Alberto Pettenò ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Diagnostic Accuracy ◽  
Prostate Biopsy ◽  
Specific Antigen ◽  
Digital Rectal Examination ◽  
Serum Levels ◽  
Immunoglobulin M ◽  
Diagnostic Tools ◽  
Psa Test ◽  
Total Psa

Background and aim The specific causes of prostate cancer (Pca) are unknown but the main risk factors of tumor development are associated with age, genetic factors, ethnicity, diet and lifestyle. Prostate cancer is rare in men under 45 years of age, but becomes more common with advancing age. The main diagnostic tools for demonstrating the presence of PCa include digital rectal examination, transrectal ultrasonography, and serum measurement of prostate specific antigen (PSA) followed by prostate biopsy for confirmation of the diagnosis. While the measurement of PSA levels has revolutionized the diagnosis of PCa, it has also increased its overdiagnosis due to the poor diagnostic accuracy. Scientific evidence indicates that biomarkers for different types of cancer such as liver and colorectal cancer circulate in the blood associated with immunoglobulin M (IgM) to form complexes that allow a better diagnosis in comparison to circulating free biomarkers. In prostate cancer it has been demonstrated that testing for serum levels of the PSA-IgM immune complex improves the diagnostic performance of total PSA. The aim of this study was to evaluate the diagnostic accuracy of PSA-IgM compared to total PSA for the selection of patients to be submitted to transrectal ultrasound-guided prostate biopsy. Patients and methods Serum samples from 67 male patients, 33 affected by PCa with a Gleason score from 5 to 7, and 34 affected by benign prostate hypertrophy (BPH), were collected by the Department of Urology of the Spedali Civili of Brescia. The samples were immediately snap frozen at −80°C. Serum levels of PSA-IgM were assessed using Prostate-IC (Xeptagen, Italy) while PSA levels were determined with the Immulite 2000 of Medical Systems S.p.A. Results Patients were stratified into 2 groups according to age; the first group consisted of 24 patients with PCa and 20 with BPH aged between 60 and 70 years and the second group consisted of 9 patients with PCa and 14 with BPH aged between 70 and 80 years. Serum levels of PSA and PSA-IgM were analyzed in the 2 groups using cutoff values of 4 ng/mL for PSA and 145 AU/mL for PSA-IgM. In the first group, 1 8 of 24 PCa patients were positive for PSA (75% sensitivity) with a specificity of 50% (10 of 20 BPH patients), and 1 0 of 24 PCa patients were positive with the PSA-IgM assay (42% sensitivity), which had a higher specificity (70%; 6 of 20 BPH patients). The combination of both biomarkers resulted in a sensitivity of 38% (9 of 24 patients with PCa) but showed a significant improvement in specificity up to 90%, since 18 of 20 patients with BPH were negative for at least one test. In the second group of patients aged 70 to 80 years, the PSA test had a sensitivity of 67% (6/9 PCa patients) and a specificity of 78% (3/14 BPH patients) compared with a sensitivity of 44% for the PSA-IgM test (4/9 PCa patients) with a specificity of 71% (4/14 BPH patients). The combination of PSA and PSA-IgM had a sensitivity of 30% (3/9) but the highest specificity (93%, 13/14 BPH patients). Conclusion The results of the study demonstrate the diagnostic value of the PSA-IgM assay compared with the total PSA test. The combination of PSA-IgM with total PSA was the best approach to reduce the number of false-positive results, thus improving the diagnosis of prostate cancer.

Evaluation of prostate cancer risk in men with PSA < 1.5.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 64-64
Author(s):  
Whitney N. Stanton ◽  
E. David Crawford ◽  
Paul Arangua ◽  
John Hoenemeyer ◽  
Francisco G. La Rosa ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Specific Antigen ◽  
Prostate Cancer Risk ◽  
Clinical Information ◽  
Mrna Levels ◽  
Protein Biomarkers ◽  
Cancer Awareness ◽  
Free Psa ◽  
Increased Risk ◽  
Total Psa

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]

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