Clinical Validation of MyProstateScore 2.0 Testing Using First-Catch, Non-Digital Rectal Examination Urine.

Area of Science:

• Urology
• Oncology
• Biomarker Discovery

Background:

• The 18-gene MyProstateScore 2.0 (MPS2) test previously required post-digital rectal examination (DRE) urine.
• Improving accessibility for prostate cancer detection is crucial.

Purpose of the Study:

• To validate the MPS2 test using first-catch, non-DRE urine for detecting grade group (GG) ≥ 2 prostate cancer.
• To assess the clinical utility of non-DRE MPS2 testing in reducing unnecessary biopsies.

Main Methods:

• Collected first-catch urine samples from 266 men prior to biopsy.
• Calculated MPS2 scores using biomarker-only, biomarker + clinical factors, and biomarker + clinical factors + prostate volume models.
• Compared MPS2 performance against PSA and the Prostate Cancer Prevention Trial risk calculator (PCPTrc) for detecting GG ≥ 2 cancer.

Main Results:

• MPS2 models demonstrated superior area under the curve (AUC) for GG ≥ 2 cancer detection (71-77%) compared to PSA (57%) and PCPTrc (62%).
• MPS2 testing could avoid 36-42% of unnecessary biopsies, significantly more than PCPTrc (13%).
• For patients with prior negative biopsies, MPS2 avoided 44-53% of repeat biopsies versus 2.6% for PCPTrc.

Conclusions:

• First-catch, non-DRE urine MPS2 testing maintains high sensitivity for GG ≥ 2 prostate cancer detection.
• Non-DRE MPS2 offers a convenient, objective, and accurate method to reduce prostate biopsy rates in men with elevated PSA.