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. 2021 Mar;205(3):732-739.
doi: 10.1097/JU.0000000000001430. Epub 2020 Oct 20.

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

Jeffrey J Tosoian  1   2   3 , Bruce J Trock  4 , Todd M Morgan  1   2 , Simpa S Salami  1   2   3 , Scott A Tomlins  1   2   3 , Daniel E Spratt  2   5 , Javed Siddiqui  1   3 , Lakshmi P Kunju  3   6 , Rachel Botbyl  3 , Zoey Chopra  3 , Balaji Pandian  3 , Nicholas W Eyrich  1 , Gary Longton  7 , Yingye Zheng  7 , Ganesh S Palapattu  1   2 , John T Wei  1   8 , Yashar S Niknafs  3 , Arul M Chinnaiyan  1   2   3   6   9
Affiliations

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

Jeffrey J Tosoian et al. J Urol. 2021 Mar.

Abstract

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.

Keywords: biomarkers; biopsy; early detection of cancer; prostate-specific antigen; prostatic neoplasms; tumor.

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Conflict of interest statement

Potential Conflicts of Interest:

JJT, YSN, and AMC are co-founders and have equity in LynxDx, which has licensed the urine biomarkers mentioned in this study from Hologic and the University of Michigan. JJT and YSN have leadership roles in Lynx Dx and AMC serves on the scientific advisory board. The University of Michigan has been issued a patent on ETS gene fusions in prostate cancer on which AMC and SAT are co-inventors. The diagnostic field of use has been licensed to LynxDx. BJT (Johns Hopkins University) has received research funding from MDxHealth and Myriad Genetics. SAT serves as CMO of Strata Oncology which was not involved in this study. LynxDx or Strata Oncology did not fund the conduct of this study.

Figures

Figure 1.
Figure 1.
Flow diagram of patients providing urine specimens prior to initial prostate biopsy in the training cohort (blue) and validation cohorts (green). MyProstateScore was assessed using the validated, locked model including serum PSA, urinary PCA3 score, and urinary T2:ERG score. The number of patients meeting National Comprehensive Cancer Network (NCCN) indications for biopsy (i.e. PSA 3–10 ng/ml or PSA <3 ng/ml and suspicious DRE) are listed for the validation cohorts (i.e. guideline-directed). EDRN: Early Detection Research Network; PSA: prostate-specific antigen; US: United States.
Figure 2.
Figure 2.
Density plots illustrating serum PSA (upper panel) and MPS (lower panel) in patients with negative (−) or Grade Group 1 (GG1) cancer on biopsy (blue) versus GG≥2 cancer on biopsy (yellow). Data are shown for A) the overall biopsy referral population and B) the guideline-directed population (i.e. PSA 3–10 ng/ml or PSA <3 ng/ml and suspicious DRE). The dashed vertical line represents a MPS value of 10.
See this image and copyright information in PMC

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