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

Area of Science:

• Urology
• Oncology
• Biomarker Discovery

Background:

• Prostate cancer detection relies on prostate-specific antigen (PSA) and risk calculators, which can lead to overdiagnosis and unnecessary biopsies.
• The MyProstateScore (MPS) test, incorporating PSA, prostate cancer antigen 3, and TMPRSS2:ERG fusion, shows promise for improved prostate cancer detection.

Purpose of the Study:

• To validate an optimal MyProstateScore threshold for ruling out clinically significant prostate cancer (grade group ≥2) in men referred for biopsy.
• To assess the performance of the MyProstateScore threshold in both overall biopsy referral populations and those meeting guideline-based testing criteria.

Main Methods:

• A multivariable model was used to calculate MyProstateScore using serum PSA, urinary PCA3, and urinary TMPRSS2:ERG.
• A training cohort identified the MyProstateScore threshold for 95% sensitivity for grade group ≥2 cancer.
• Performance was evaluated in two external validation cohorts (academic and community settings).

Main Results:

• In 1,525 patients, an MyProstateScore threshold of 10 demonstrated 97% sensitivity and 98% negative predictive value for grade group ≥2 cancer.
• MyProstateScore testing could have prevented 33% of unnecessary biopsies, missing only 3.0% of significant cancers.
• In guideline-eligible patients, MyProstateScore ≤10 achieved 96% sensitivity and 97% negative predictive value, preventing 32% of biopsies.

Conclusions:

• MyProstateScore ≤10 offers high sensitivity and negative predictive value for excluding clinically significant prostate cancer in biopsy-referred men.
• This secondary testing strategy can reduce unnecessary invasive procedures following initial PSA screening.
• The validated MyProstateScore threshold provides a practical tool for optimizing prostate cancer diagnostic pathways.