Use of the MyProstateScore Test to Rule Out Clinically Significant Cancer: Validation of a Straightforward Clinical Testing Approach

Tosoian, Jeffrey J.; Trock, Bruce J.; Morgan, Todd M.; Salami, Simpa S.; Tomlins, Scott A.; Spratt, Daniel E.; Siddiqui, Javed; Kunju, Lakshmi P.; Botbyl, Rachel; Chopra, Zoey; Pandian, Balaji; Eyrich, Nicholas W.; Longton, Gary; Zheng, Yingye; Palapattu, Ganesh S.; Wei, John T.; Niknafs, Yashar S.; Chinnaiyan, Arul M.

doi:10.1097/ju.0000000000001430

Cited by 28 publications

(36 citation statements)

References 33 publications

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“…Given this fact and reports of unexplained PCA3 well above the cut-off [15] without cancer on biopsy, it is reasonable to use newer, more sensitive and specific diagnostic tools to detect patients requiring prompt and radical treatment. For example, PCA3 in combination with other biomarkers such as TM-PRSS2: ERG fusion [36] in Mi-Prostate Score [41][42][43][44][45][46] or ERG and SPDEF in ExoDx Prostate IntelliScore [47,48,[61][62][63], where it shows better diagnostic and prognostic potential.…”

Section: Discussionmentioning

confidence: 99%

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Prostate Cancer Liquid Biopsy Biomarkers’ Clinical Utility in Diagnosis and Prognosis

Matuszczak

Schalken

Salagierski

2021

Cancers

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Prostate cancer (PCa) is the most common cancer in men worldwide. The current gold standard for diagnosing PCa relies on a transrectal ultrasound-guided systematic core needle biopsy indicated after detection changes in a digital rectal examination (DRE) and elevated prostate-specific antigen (PSA) level in the blood serum. PSA is a marker produced by prostate cells, not just cancer cells. Therefore, an elevated PSA level may be associated with other symptoms such as benign prostatic hyperplasia or inflammation of the prostate gland. Due to this marker’s low specificity, a common problem is overdiagnosis, which leads to unnecessary biopsies and overtreatment. This is associated with various treatment complications (such as bleeding or infection) and generates unnecessary costs. Therefore, there is no doubt that the improvement of the current procedure by applying effective, sensitive and specific markers is an urgent need. Several non-invasive, cost-effective, high-accuracy liquid biopsy diagnostic biomarkers such as Progensa PCA3, MyProstateScore ExoDx, SelectMDx, PHI, 4K, Stockholm3 and ConfirmMDx have been developed in recent years. This article compares current knowledge about them and their potential application in clinical practice.

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Section: Discussionmentioning

confidence: 99%

“…An MPS threshold of ≤10 was recommended. At this value, sensitivity (96%) and NPV (97%) were obtained, avoiding 32% of unnecessary biopsies while missing 3.7% of GG cancer cases ≥ 2 (Table 3) [46].…”

Section: Mi-prostate Score (Mips)mentioning

confidence: 97%

Prostate Cancer Liquid Biopsy Biomarkers’ Clinical Utility in Diagnosis and Prognosis

Matuszczak

Schalken

Salagierski

2021

Cancers

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“…Nonetheless, considering both (i) the practical limitations of mpMRI (e.g. subjective interpretation, high inter-reader variability, high relative cost and resource burden) 29,30 and (ii) the very high negative predictive value of MPS (98%) on recent validation, 31 MPS could be useful as a first-line test to rule-out high-grade cancer prior to more invasive testing.…”

Section: Discussionmentioning

confidence: 99%

Impact of the MyProstateScore (MPS) test on the clinical decision to undergo prostate biopsy: results from a contemporary academic practice

Lebastchi¹,

Russell²,

Niknafs³

et al. 2020

Preprint

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Objective: To evaluate the association of the MyProstateScore (MPS) urine test on the decision to undergo biopsy in men referred for prostate biopsy at a contemporary academic urology practice. Methods: MPS testing was offered as an alternative to immediate biopsy in men referred to the University of Michigan for prostate biopsy from October 2013 through October 2016. The primary endpoint was the decision to perform biopsy. The proportion of patients who underwent biopsy was calculated across MPS quintiles and compared to predicted risk scores from the Prostate Cancer Prevention Trial risk calculator (PCPTrc). Analyses were performed in the overall referral population and the intended-use population (PSA 3-10 ng/ml or PSA <3 ng/ml and abnormal DRE) and stratified by the use of multiparametric magnetic resonance imaging (mpMRI). The associations of PCPTrc, MPS, and mpMRI with the decision to undergo biopsy were explored in a multivariable logistic regression model. Results: Of 248 patients, 134 (54%) proceeded to prostate biopsy. Clinical variables, PSA, and PCPTrc score did not significantly differ based on the decision to undergo biopsy, while MPS was significantly higher in biopsied patients (median 29 vs. 14, p<0.001). The use of biopsy was strongly associated with MPS, with biopsy rates of 26%, 38%, 58%, 90%, and 85% in the first through fifth MPS quintiles, respectively (p<0.001). By contrast, biopsy rates were 51%, 47%, 52%, 69%, and 52% by increasing PCPTrc score quintile (p=0.3). The association of MPS with biopsy persisted upon stratification by use of mpMRI. On multivariable analysis, MPS was strongly associated with the decision to undergo biopsy when modeled as both a continuous variable (odds ratio [OR] 1.05 per 1 unit increase, 95% confidence interval [CI] 1.04-1.08; <0.001) and binary variable (OR 7.76, 95% CI 4.14-14.5; p<0.001). These findings were consistent in the overall and intended-use populations. Conclusion: In a cohort of patients who underwent clinical MPS testing as an alternative to immediate prostate biopsy, 46% were able to avoid biopsy and increasing MPS was strongly associated with biopsy rates. These findings were robust to the use of mpMRI and consistent across pertinent subpopulations. Overall, these data suggest that the MPS assay may substantially reduce the number of men undergoing prostate needle biopsy.

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“…These findings were confirmed in 1,242 patients meeting testing criteria consistent with the National Comprehensive Cancer Network (i.e., PSA 3-10 ng/mL or PSA <3 and suspicious DRE) and in clinicallypertinent subgroups (i.e., African-American men and men with suspicious DRE). Applied as a reflex clinical test, MPS would have prevented 33% of unnecessary biopsies while failing to detect only 3.0% of GG ≥2 cancers (69). These data are listed in Table 7.…”

Section: Myprostatescore (Mps)mentioning

confidence: 99%

Biomarkers for detection of clinically significant prostate cancer: contemporary clinical data and future directions

Eyrich¹,

Morgan²,

Tosoian³

2021

Transl Androl Urol

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Use of serum prostate-specific antigen (PSA) testing for early detection of prostate cancer appears to reduce cancer-specific mortality. Due to the limited specificity of PSA for clinically significant [Grade Group (GG) ≥2] cancer, however, screening carries substantial risks, including frequent unnecessary prostate biopsies and overdetection of non-aggressive cancers. To that end, serum and urine biomarkers with improved specificity for GG ≥2 cancer have been proposed for clinical use following PSA. In the current article, we present clinical validation data for five such biomarkers: PHI, 4Kscore, SelectMDx, ExoDx, and MPS. For all studies, we specify the study population (overall biopsy referral vs. pre-specified PSA ranges), previous biopsy status (biopsy-naïve vs. previous negative biopsy), and the proportion of subjects diagnosed with GG ≥2 cancer.Outcomes include test performance characteristics: sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV). Published data were used to compute the number of unnecessary biopsies avoided and number of GG ≥2 cancers missed if the biomarker had been used clinically to select for prostate biopsy. The evidence review is preceded by a primer on these and other clinically-relevant summary statistics.

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Use of the MyProstateScore Test to Rule Out Clinically Significant Cancer: Validation of a Straightforward Clinical Testing Approach

Cited by 28 publications

References 33 publications

Prostate Cancer Liquid Biopsy Biomarkers’ Clinical Utility in Diagnosis and Prognosis

Prostate Cancer Liquid Biopsy Biomarkers’ Clinical Utility in Diagnosis and Prognosis

Impact of the MyProstateScore (MPS) test on the clinical decision to undergo prostate biopsy: results from a contemporary academic practice

Biomarkers for detection of clinically significant prostate cancer: contemporary clinical data and future directions

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