Development and evaluation of the MiCheck test for aggressive prostate cancer

•MiCheck test is a blood test developed to detect aggressive prostate cancer.•Uses an algorithm containing clinical factors and soluble analytes to give a risk score.•Outperforms existing tests in differentiating aggressive from nonaggressive prostate cancer.•Has potential to significantly reduce bi...

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Published inUrologic oncology Vol. 38; no. 8; pp. 683.e11 - 683.e18
Main Authors Shore, Neal D., Pieczonka, Christopher M., Henderson, R. Jonathan, Bailen, James L., Saltzstein, Daniel R., Concepcion, Raoul S., Beebe-Dimmer, Jennifer L., Ruterbusch, Julie J., Levin, Rachel A., Wissmueller, Sandra, Le, Thao Ho, Gillatt, David, Chan, Daniel W., Campbell, Douglas H., Walsh, Bradley J.
Format Journal Article
LanguageEnglish
Published United States Elsevier Inc 01.08.2020
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Abstract •MiCheck test is a blood test developed to detect aggressive prostate cancer.•Uses an algorithm containing clinical factors and soluble analytes to give a risk score.•Outperforms existing tests in differentiating aggressive from nonaggressive prostate cancer.•Has potential to significantly reduce biopsies and healthcare costs. A clinical need exists for a biomarker test to accurately delineate aggressive prostate cancer (AgCaP), and thus better assist clinicians and patients decision-making on whether to proceed to prostate biopsy. To develop a blood test for AgCaP and compare to PSA, %free PSA, proPSA, and prostate health index (PHI) tests. Patient samples from the MiCheck-01 trial were used for development of the MiCheck test. Serum analyte concentrations for cellular growth factors were determined using a custom-made Luminex-based R&D Systems multianalyte kit. Bayesian model averaging and random forest approaches were used to identify clinical factors and growth factors able to distinguish between men with AgCaP (Gleason Score [GS] ≥3+4) from those with non-AgCaP (GS 3+3). Logistic regression and Monte Carlo cross-validation identified variable combinations in order to able to maximize differentiation of AgCaP from non-AgCaP. The MiCheck logistic regression model was developed and comprises the following variables: serum prostate-specific antigen (PSA), patient age, Digital Rectal Exam (DRE) status, Leptin, IL-7, vascular endothelial growth factor, and Glypican-1. The model differentiated AgCaP from non-AgCaP with an area under the curve of 0.83 and was superior to PSA, %free PSA and PHI in all patient groups, regardless of PSA range. Applying the MiCheck test to all evaluable biopsy patients from the MiCheck-01 study demonstrated that up to 30% of biopsies could be avoided while delaying diagnosis of only 6.8% of GS ≥3+4 cancers, 5% of GS ≥4+3 cancers and no cancers of GS 8 or higher. The MiCheck test outperforms PSA, %free PSA and PHI tests in differentiating AgCaP vs. non-AgCaP patients. The MiCheck test could result in a significant number of biopsies being avoided with a low number of patients experiencing a delayed diagnosis.
AbstractList •MiCheck test is a blood test developed to detect aggressive prostate cancer.•Uses an algorithm containing clinical factors and soluble analytes to give a risk score.•Outperforms existing tests in differentiating aggressive from nonaggressive prostate cancer.•Has potential to significantly reduce biopsies and healthcare costs. A clinical need exists for a biomarker test to accurately delineate aggressive prostate cancer (AgCaP), and thus better assist clinicians and patients decision-making on whether to proceed to prostate biopsy. To develop a blood test for AgCaP and compare to PSA, %free PSA, proPSA, and prostate health index (PHI) tests. Patient samples from the MiCheck-01 trial were used for development of the MiCheck test. Serum analyte concentrations for cellular growth factors were determined using a custom-made Luminex-based R&D Systems multianalyte kit. Bayesian model averaging and random forest approaches were used to identify clinical factors and growth factors able to distinguish between men with AgCaP (Gleason Score [GS] ≥3+4) from those with non-AgCaP (GS 3+3). Logistic regression and Monte Carlo cross-validation identified variable combinations in order to able to maximize differentiation of AgCaP from non-AgCaP. The MiCheck logistic regression model was developed and comprises the following variables: serum prostate-specific antigen (PSA), patient age, Digital Rectal Exam (DRE) status, Leptin, IL-7, vascular endothelial growth factor, and Glypican-1. The model differentiated AgCaP from non-AgCaP with an area under the curve of 0.83 and was superior to PSA, %free PSA and PHI in all patient groups, regardless of PSA range. Applying the MiCheck test to all evaluable biopsy patients from the MiCheck-01 study demonstrated that up to 30% of biopsies could be avoided while delaying diagnosis of only 6.8% of GS ≥3+4 cancers, 5% of GS ≥4+3 cancers and no cancers of GS 8 or higher. The MiCheck test outperforms PSA, %free PSA and PHI tests in differentiating AgCaP vs. non-AgCaP patients. The MiCheck test could result in a significant number of biopsies being avoided with a low number of patients experiencing a delayed diagnosis.
BACKGROUNDA clinical need exists for a biomarker test to accurately delineate aggressive prostate cancer (AgCaP), and thus better assist clinicians and patients decision-making on whether to proceed to prostate biopsy. OBJECTIVESTo develop a blood test for AgCaP and compare to PSA, %free PSA, proPSA, and prostate health index (PHI) tests. DESIGN, SETTINGS AND PARTICIPANTSPatient samples from the MiCheck-01 trial were used for development of the MiCheck test. METHODSSerum analyte concentrations for cellular growth factors were determined using a custom-made Luminex-based R&D Systems multianalyte kit. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSISBayesian model averaging and random forest approaches were used to identify clinical factors and growth factors able to distinguish between men with AgCaP (Gleason Score [GS] ≥3+4) from those with non-AgCaP (GS 3+3). Logistic regression and Monte Carlo cross-validation identified variable combinations in order to able to maximize differentiation of AgCaP from non-AgCaP. RESULTSThe MiCheck logistic regression model was developed and comprises the following variables: serum prostate-specific antigen (PSA), patient age, Digital Rectal Exam (DRE) status, Leptin, IL-7, vascular endothelial growth factor, and Glypican-1. The model differentiated AgCaP from non-AgCaP with an area under the curve of 0.83 and was superior to PSA, %free PSA and PHI in all patient groups, regardless of PSA range. Applying the MiCheck test to all evaluable biopsy patients from the MiCheck-01 study demonstrated that up to 30% of biopsies could be avoided while delaying diagnosis of only 6.8% of GS ≥3+4 cancers, 5% of GS ≥4+3 cancers and no cancers of GS 8 or higher. CONCLUSIONSThe MiCheck test outperforms PSA, %free PSA and PHI tests in differentiating AgCaP vs. non-AgCaP patients. The MiCheck test could result in a significant number of biopsies being avoided with a low number of patients experiencing a delayed diagnosis.
A clinical need exists for a biomarker test to accurately delineate aggressive prostate cancer (AgCaP), and thus better assist clinicians and patients decision-making on whether to proceed to prostate biopsy. To develop a blood test for AgCaP and compare to PSA, %free PSA, proPSA, and prostate health index (PHI) tests. Patient samples from the MiCheck-01 trial were used for development of the MiCheck test. Serum analyte concentrations for cellular growth factors were determined using a custom-made Luminex-based R&D Systems multianalyte kit. Bayesian model averaging and random forest approaches were used to identify clinical factors and growth factors able to distinguish between men with AgCaP (Gleason Score [GS] ≥3+4) from those with non-AgCaP (GS 3+3). Logistic regression and Monte Carlo cross-validation identified variable combinations in order to able to maximize differentiation of AgCaP from non-AgCaP. The MiCheck logistic regression model was developed and comprises the following variables: serum prostate-specific antigen (PSA), patient age, Digital Rectal Exam (DRE) status, Leptin, IL-7, vascular endothelial growth factor, and Glypican-1. The model differentiated AgCaP from non-AgCaP with an area under the curve of 0.83 and was superior to PSA, %free PSA and PHI in all patient groups, regardless of PSA range. Applying the MiCheck test to all evaluable biopsy patients from the MiCheck-01 study demonstrated that up to 30% of biopsies could be avoided while delaying diagnosis of only 6.8% of GS ≥3+4 cancers, 5% of GS ≥4+3 cancers and no cancers of GS 8 or higher. The MiCheck test outperforms PSA, %free PSA and PHI tests in differentiating AgCaP vs. non-AgCaP patients. The MiCheck test could result in a significant number of biopsies being avoided with a low number of patients experiencing a delayed diagnosis.
Author Bailen, James L.
Concepcion, Raoul S.
Gillatt, David
Walsh, Bradley J.
Henderson, R. Jonathan
Wissmueller, Sandra
Chan, Daniel W.
Shore, Neal D.
Le, Thao Ho
Saltzstein, Daniel R.
Levin, Rachel A.
Ruterbusch, Julie J.
Campbell, Douglas H.
Beebe-Dimmer, Jennifer L.
Pieczonka, Christopher M.
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Snippet •MiCheck test is a blood test developed to detect aggressive prostate cancer.•Uses an algorithm containing clinical factors and soluble analytes to give a risk...
A clinical need exists for a biomarker test to accurately delineate aggressive prostate cancer (AgCaP), and thus better assist clinicians and patients...
BACKGROUNDA clinical need exists for a biomarker test to accurately delineate aggressive prostate cancer (AgCaP), and thus better assist clinicians and...
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Publisher
StartPage 683.e11
SubjectTerms Aged
Aged, 80 and over
Aggressive
Biomarker
Clinical study
Hematologic Tests - statistics & numerical data
Humans
Male
Middle Aged
Monte Carlo Method
Neoplasm Grading
Prostate
Prostate-Specific Antigen - blood
Prostatic Neoplasms - blood
Prostatic Neoplasms - diagnosis
Title Development and evaluation of the MiCheck test for aggressive prostate cancer
URI https://dx.doi.org/10.1016/j.urolonc.2020.03.010
https://www.ncbi.nlm.nih.gov/pubmed/32305266
https://search.proquest.com/docview/2392470525
Volume 38
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