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

Autor:	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.
Jazyk:	angličtina
Zdroj:	The Journal of urology [J Urol] 2021 Mar; Vol. 205 (3), pp. 732-739. Date of Electronic Publication: 2020 Oct 20.
DOI:	10.1097/JU.0000000000001430
Abstrakt:	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.
Databáze:	MEDLINE
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