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Tytuł:
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Use of the MyProstateScore Test to Rule Out Clinically Significant Cancer: Validation of a Straightforward Clinical Testing Approach.
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Autorzy:
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Tosoian JJ; Department of Urology, University of Michigan, Ann Arbor, Michigan.; Rogel Cancer Center, University of Michigan, Ann Arbor, Michigan.; Michigan Center for Translational Pathology, University of Michigan, Ann Arbor, Michigan.
Trock BJ; Johns Hopkins Brady Urological Institute, Baltimore, Maryland.
Morgan TM; Department of Urology, University of Michigan, Ann Arbor, Michigan.; Rogel Cancer Center, University of Michigan, Ann Arbor, Michigan.
Salami SS; Department of Urology, University of Michigan, Ann Arbor, Michigan.; Rogel Cancer Center, University of Michigan, Ann Arbor, Michigan.; Michigan Center for Translational Pathology, University of Michigan, Ann Arbor, Michigan.
Tomlins SA; Department of Urology, University of Michigan, Ann Arbor, Michigan.; Rogel Cancer Center, University of Michigan, Ann Arbor, Michigan.; Michigan Center for Translational Pathology, University of Michigan, Ann Arbor, Michigan.
Spratt DE; Rogel Cancer Center, University of Michigan, Ann Arbor, Michigan.; Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
Siddiqui J; Department of Urology, University of Michigan, Ann Arbor, Michigan.; Michigan Center for Translational Pathology, University of Michigan, Ann Arbor, Michigan.
Kunju LP; Michigan Center for Translational Pathology, University of Michigan, Ann Arbor, Michigan.; Department of Pathology, University of Michigan, Ann Arbor, Michigan.
Botbyl R; Michigan Center for Translational Pathology, University of Michigan, Ann Arbor, Michigan.
Chopra Z; Michigan Center for Translational Pathology, University of Michigan, Ann Arbor, Michigan.
Pandian B; Michigan Center for Translational Pathology, University of Michigan, Ann Arbor, Michigan.
Eyrich NW; Department of Urology, University of Michigan, Ann Arbor, Michigan.
Longton G; Biostatistics Program, Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Zheng Y; Biostatistics Program, Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Palapattu GS; Department of Urology, University of Michigan, Ann Arbor, Michigan.; Rogel Cancer Center, University of Michigan, Ann Arbor, Michigan.
Wei JT; Department of Urology, University of Michigan, Ann Arbor, Michigan.; Dow Division of Health Services Research, University of Michigan, Ann Arbor, Michigan.
Niknafs YS; Michigan Center for Translational Pathology, University of Michigan, Ann Arbor, Michigan.
Chinnaiyan AM; Department of Urology, University of Michigan, Ann Arbor, Michigan.; Rogel Cancer Center, University of Michigan, Ann Arbor, Michigan.; Michigan Center for Translational Pathology, University of Michigan, Ann Arbor, Michigan.; Department of Pathology, University of Michigan, Ann Arbor, Michigan.; Howard Hughes Medical Institute, University of Michigan, Ann Arbor, Michigan.
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Źródło:
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The Journal of urology [J Urol] 2021 Mar; Vol. 205 (3), pp. 732-739. Date of Electronic Publication: 2020 Oct 20.
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Typ publikacji:
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Journal Article; Research Support, N.I.H., Extramural; Validation Study
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Język:
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English
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Imprint Name(s):
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Publication: 2019- : [Philadelphia, PA] : Wolters Kluwer
Original Publication: Baltimore : Lippincott Williams & Wilkins
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MeSH Terms:
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Antigens, Neoplasm/*urine
Prostate-Specific Antigen/*blood
Prostatic Neoplasms/*blood
Prostatic Neoplasms/*urine
Serine Endopeptidases/*urine
Aged ; Biomarkers, Tumor/blood ; Biomarkers, Tumor/urine ; Biopsy ; Digital Rectal Examination ; Humans ; Male ; Middle Aged ; Neoplasm Grading ; Predictive Value of Tests ; Prospective Studies ; Prostatic Neoplasms/pathology ; Referral and Consultation/statistics & numerical data ; Risk Assessment/methods ; Sensitivity and Specificity
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References:
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Grant Information:
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T32 CA180984 United States CA NCI NIH HHS; R35 CA231996 United States CA NCI NIH HHS; R21 AI080984 United States AI NIAID NIH HHS; U01 CA214170 United States CA NCI NIH HHS; T32 GM007863 United States GM NIGMS NIH HHS; R01 CA236558 United States CA NCI NIH HHS; P50 CA186786 United States CA NCI NIH HHS
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Contributed Indexing:
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Keywords: biomarkers; biopsy; early detection of cancer; prostate-specific antigen; prostatic neoplasms; tumor
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Substance Nomenclature:
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0 (Antigens, Neoplasm)
0 (Biomarkers, Tumor)
0 (prostate cancer antigen 3, human)
EC 3.4.21.- (Serine Endopeptidases)
EC 3.4.21.- (TMPRSS2 protein, human)
EC 3.4.21.77 (Prostate-Specific Antigen)
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Entry Date(s):
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Date Created: 20201020 Date Completed: 20210414 Latest Revision: 20221224
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Update Code:
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20240105
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PubMed Central ID:
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PMC8189629
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DOI:
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10.1097/JU.0000000000001430
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PMID:
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33080150
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Purpose: The MyProstateScore test was validated for improved detection of clinically significant (grade group ≥2) prostate cancer relative to prostate specific antigen based risk calculators. We sought to validate an optimal MyProstateScore threshold for clinical use in ruling out grade group ≥2 cancer in men referred for biopsy.
Materials and Methods: Biopsy naïve men provided post-digital rectal examination urine prior to biopsy. MyProstateScore was calculated using the validated, locked multivariable model including only serum prostate specific antigen, urinary prostate cancer antigen 3 and urinary TMPRSS2:ERG. The MyProstateScore threshold approximating 95% sensitivity for grade group ≥2 cancer was identified in a training cohort, and performance was measured in 2 external validation cohorts. We assessed the 1) overall biopsy referral population and 2) population meeting guideline based testing criteria (ie, prostate specific antigen 3-10, or <3 with suspicious digital rectal examination).
Results: Validation cohorts were prospectively enrolled from academic (977 patients, median prostate specific antigen 4.5, IQR 3.1-6.0) and community (548, median prostate specific antigen 4.9, IQR 3.7-6.8) settings. In the overall validation population (1,525 patients), 338 men (22%) had grade group ≥2 cancer on biopsy. The MyProstateScore threshold of 10 provided 97% sensitivity and 98% negative predictive value for grade group ≥2 cancer. MyProstateScore testing would have prevented 387 unnecessary biopsies (33%), while missing only 10 grade group ≥2 cancers (3.0%). In 1,242 patients meeting guideline based criteria, MyProstateScore ≤10 provided 96% sensitivity and 97% negative predictive value, and would have prevented 32% of unnecessary biopsies, missing 3.7% of grade group ≥2 cancers.
Conclusions: In a large, clinically pertinent biopsy referral population, MyProstateScore ≤10 provided exceptional sensitivity and negative predictive value for ruling out grade group ≥2 cancer. This straightforward secondary testing approach would reduce the use of more costly and invasive procedures after screening with prostate specific antigen.
