Presentation Authors: Sanoj Punnen*, Miami, FL, Eric Kim, St. Louis, WA, Niranjan Sathianathen, Badrinath Konety, Minneapolis, MN, Stefan Czarniecki, poland, Poland, Ali Kasraeian, Sarasota, FL
Introduction: mpMRI and new biomarkers have emerged as popular alternatives prior to prostate biopsy (Bx). We sought to investigate a combination of 4Kscore and mpMRI to improve diagnostic performance, and potentially further reduce Bx rates compared to the individual tests alone
Methods: This was a retrospective, five-center study of men who underwent a 4Kscore, mpMRI, and Bx. Results from mpMRI were reported using PIRADS and categorized into low (PIRADS 1-2), intermediate (PIRADS 3) and high (PIRADS 4-5). The 4Kscore is reported as a continuous probability of high-grade GG2 or higher cancer (HG), here categorized into low ( < 7%), intermediate (8%-32%), and high (>33%) risk. The primary endpoint was to evaluate potential Bx reduction, sensitivity, negative predictive value (NPV), and undetected HG cancers when using Single Test or Combination Test strategies for Bx decision-making.. We evaluated using either test alone, versus both tests in sequence. With Single Test, patients were stratified with low risk results avoiding a Bx and intermediate or high risk getting a Bx. With Combination Test, high-risk patients by the first test would receive a Bx and low risk would not. For intermediate risk patients, the second test would be used for determining if a Bx would occur (Fig. 1).
Results: The final cohort included 407 men, of which 114 were found to have a HG cancer. Using a 4Kscore or MRI alone, resulted in a 25-27% biopsy reduction, with 8-12 men having an undetected HG. Combination strategies yielded higher specificities, leading to larger biopsy reductions in the range of 38-41%, while 11-15 men had an undetected HG. Sensitivity and NPV did not appreciably differ between strategies (Table 1). Similar results were found in the category of men with a PSA of 2-10 and 3-10 ng/mL.
Conclusions: Combining 4Kscore and mpMRI to make prostate Bx decisions could further reduce Bx rates, while improving specificity for high-grade cancer, with minimal changes to NPV and sensitivity