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. 2023 Sep;26(3):563-567.
doi: 10.1038/s41391-022-00633-3. Epub 2022 Dec 30.

MyProstateScore in men considering repeat biopsy: validation of a simple testing approach

Jeffrey J Tosoian #  1   2   3   4   5 , Michael S Sessine #  6 , Bruce J Trock  7 , Ashley E Ross  8 , Cassie Xie  9 , Yingye Zheng  9 , Nathan L Samora  10 , Javed Siddiqui  11 , Yashar Niknafs  11 , Zoey Chopra  11 , Scott Tomlins  11 , Lakshmi P Kunju  11   12 , Ganesh S Palapattu  13   14 , Todd M Morgan  13   14 , John T Wei  13 , Simpa S Salami  13   14 , Arul M Chinnaiyan  13   14   11   12   15
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MyProstateScore in men considering repeat biopsy: validation of a simple testing approach

Jeffrey J Tosoian et al. Prostate Cancer Prostatic Dis. 2023 Sep.

Abstract

Background: Men with persistent risk of Grade Group (GG) ≥ 2 cancer after a negative biopsy present a unique clinical challenge. The validated MyProstateScore test is clinically-available for pre-biopsy risk stratification. In biopsy-naïve patients, we recently validated a straightforward testing approach to rule-out GG ≥ 2 cancer with 98% negative predictive value (NPV) and 97% sensitivity. In the current study, we established a practical MPS-based testing approach in men with a previous negative biopsy being considered for repeat biopsy.

Methods: Patients provided post-digital rectal examination urine prior to repeat biopsy. MyProstateScore was calculated using the validated, locked model including urinary PCA3 and TMPRSS2:ERG scores with serum PSA. In a clinically-appropriate primary (i.e., training) cohort, we identified a lower (rule-out) threshold approximating 90% sensitivity and an upper (rule-in) threshold approximating 80% specificity for GG ≥ 2 cancer. These thresholds were applied to an external validation cohort, and performance measures and clinical outcomes associated with their use were calculated.

Results: MyProstateScore thresholds of 15 and 40 met pre-defined performance criteria in the primary cohort (422 patients; median PSA 6.4, IQR 4.3-9.1). In the 268-patient validation cohort, 25 men (9.3%) had GG ≥ 2 cancer on repeat biopsy. The rule-out threshold of 15 provided 100% NPV and sensitivity for GG ≥ 2 cancer and would have prevented 23% of unnecessary biopsies. Use of MyProstateScore >40 to rule-in biopsy would have prevented 67% of biopsies while maintaining 95% NPV. In the validation cohort, the prevalence of GG ≥ 2 cancer was 0% for MyProstateScore 0-15, 6.5% for MyProstateScore 15-40, and 19% for MyProstateScore >40.

Conclusions: In patients who previously underwent a negative prostate biopsy, the MyProstateScore values of 15 and 40 yielded clinically-actionable rule-in and rule-out risk groups. Using this straightforward testing approach, MyProstateScore can meaningfully inform patients and physicians weighing the need for repeat biopsy.

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Conflict of interest statement

JJT and AMC are advisors with equity interest in LynxDx. MSS and YZ are consultants to LynxDx. AMC and SAT are co-inventors on a patent issued to The University of Michigan (UM) on ETS gene fusions in prostate cancer and are included in the royalty distribution stream (managed by UM). The patent is currently licensed to LynxDx.

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