Presented by: Mark I Sultan MD
University of California, Irvine

Introduction

The use of Magnetic Resonance Imaging (MRI) and noninvasive biomarker for biopsy decision making has been rising among urologists. We aim to assess the diagnostic performance and utility of the ExoDx IntelliScore and an OPKO4K score to predict prostate cancer in men presenting with elevated Prostate Specific Antigen (PSA) - both as independent predictors and in combination with clinical/MRI imaging characteristics.

Materials

Patients with elevated PSA from 2017-2020 were retrospectively reviewed. Abnormal tests were defined as an OPKO4K score≥7.5% and an ExoDx IntelliScore≥15.6. Four regression models and receiver-operator characteristic (ROC) curves were generated based on: (1) age, baseline PSA, and digital rectal exam, (2) model 1 + OPKO4K 4Kscore≥7.5%, (3) model 2 + ExoDx IntelliScore≥15.6, and (4) model 3 + MRI PIRADS 4-5.

Results

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359 men received an OPKO4K test, 307 had MRI and 113 had ExoDx tests. Ultimately, 163 men proceeded to prostate biopsy and 196 (55%) were saved from invasive biopsies after discussion of additional testing. Mean age was 65.0±8.7 years and mean baseline PSA was 7.1±6.1ng/ml. Positive biopsies were found in 84 (51.5%) men. The sensitivity and negative predictive value of an OPKO4K score were 86.7% and 72.3%; values for an ExoDx test were 76.5% and 77.1%, respectively.

Opko4K score, ExoDx IntelliScore, and MRI characteristics significantly improved predictive capability. On logistic regression modeling, classical clinical markers (Age, PSA, DRE) generated an AUC of 0.559. The addition of an OPKO4K score raised the AUC to 0.653. The stepwise addition of an ExoDx score raised the AUC to 0.766. The combined use of both biomarkers, patient characteristics, and MRI results yielded an AUC of 0.825.

Conclusion

This analysis demonstrates the high negative predictive value of both the OPKO4K score and ExoDX IntelliScore independently – while demonstrating that the combination of an OPKO4K score with an ExoDX IntelliScore also increases diagnostic accuracy. A model combining an ExoDx Prostate test with an OPKO4K score, MP-MRI, DRE, and patient serum PSA displayed high predictive capability for biopsy confirmed prostate cancer. Our data supports prospective evaluation of diagnostic algorithm combining non-invasive biomarkers with MRI for prostate biopsy decision making.  

Funding

None

Lead Authors

Mark I Sultan, MD
University of California, Irvine

Co-Authors

Linda M Huynh,
University of California, Irvine

Sarah Kamil,
University of California, Irvine

Ahmad Abdelaziz, MBBCh
University of California, Irvine

Muhammed A Hammad, MBBCh
University of California, Irvine

Greg E Gin, MD
University of California, Irvine

David I Lee, MD
University of California, Irvine

Ramy Youssef, MD
University of California, Irvine