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

Area of Science:

• Urology
• Oncology
• Biomarker Development

Background:

• Men with persistent risk of Grade Group (GG) ≥2 prostate cancer after a negative biopsy face clinical challenges.
• The MyProstateScore (MPS) test is a validated tool for pre-biopsy risk stratification.
• Previous studies validated MPS for ruling out GG ≥2 cancer in biopsy-naïve patients with high negative predictive value (NPV) and sensitivity.

Purpose of the Study:

• To establish a practical MPS-based testing approach for men with a prior negative biopsy.
• To define MPS thresholds for ruling out or ruling in repeat prostate biopsy.
• To evaluate the clinical utility and performance of MPS in this patient population.

Main Methods:

• Urine samples were collected post-digital rectal examination prior to repeat biopsy.
• MyProstateScore was calculated using a locked model including urinary PCA3, TMPRSS2:ERG, and serum PSA.
• Pre-defined rule-out (approx. 90% sensitivity) and rule-in (approx. 80% specificity) thresholds were applied to primary and external validation cohorts.

Main Results:

• In the validation cohort (268 men), MPS thresholds of 15 and 40 were established.
• A rule-out threshold of 15 demonstrated 100% NPV and sensitivity for GG ≥2 cancer, potentially preventing 23% of biopsies.
• An MPS >40 rule-in threshold could prevent 67% of biopsies with 95% NPV, identifying men with 19% prevalence of GG ≥2 cancer.

Conclusions:

• MyProstateScore values of 15 and 40 create clinically actionable risk groups for men with prior negative biopsies.
• This MPS testing approach provides valuable information for decisions regarding repeat prostate biopsy.
• MPS can meaningfully inform patient and physician discussions about the necessity of repeat biopsy.