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. 2024 Feb;56(2):539-546.
doi: 10.1007/s11255-023-03786-9. Epub 2023 Sep 24.

Utility of noninvasive biomarker testing and MRI to predict a prostate cancer diagnosis

Mark I Sultan  1 , Linda M Huynh  1 , Sarah Kamil  1 , Ahmad Abdelaziz  1 , Muhammed A Hammad  1 , Greg E Gin  1 , David I Lee  1 , Ramy F Youssef  2
Affiliations

Utility of noninvasive biomarker testing and MRI to predict a prostate cancer diagnosis

Mark I Sultan et al. Int Urol Nephrol. 2024 Feb.

Abstract

Purpose: To assess the diagnostic performance and utility of the ExoDx IntelliScore and an OPKO4K score to predict prostate cancer in men presenting with elevated PSA-both as independent predictors and in combination with clinical/MRI characteristics.

Methods: Patients with elevated PSA were retrospectively reviewed. Abnormal tests were defined as an OPKO4K score ≥ 7.5% and an ExoDx IntelliScore ≥ 15.6. Four regression models and ROC curves were generated based on: (1) age, PSA, and DRE, (2) model 1 + OPKO4K 4Kscore ≥ 7.5%, (3) model 2 + ExoDx IntelliScore ≥ 15.6, and (4) model 3 + MRI PIRADS 4-5.

Results: 359 men received an OPKO4K test, 307 had MRI and 113 had ExoDx tests. 163 men proceeded to prostate biopsy and 196 (55%) were saved from biopsy. Mean age was 65.0 ± 8.7 years and mean PSA was 7.1 ± 6.1 ng/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. On regression analysis, 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 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, an ExoDX IntelliScore, and MRI increases predictive capability for biopsy confirmed prostate cancer.

Keywords: 4K score; ExoDx IntelliScore; Noninvasive prostate cancer testing; Prostate MRI; Prostate biopsy.

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Conflict of interest statement

The authors have no relevant financial or non-financial interests to disclose.

Figures

Fig. 1
Fig. 1
An axial T2-weighted image on a 3 T prostate MRI demonstrating a PI-RADS 5 lesion in the left peripheral mid gland
Fig. 2
Fig. 2
H + E low power view of patient region of interest biopsy demonstrating Gleason score 4 + 5 (GG5) prostate adenocarcinoma
Fig. 3
Fig. 3
ROC curve based on a positive biopsy endpoint of a baseline patient characteristics, b baseline patient characteristics and the addition of OPKO4K Score, c baseline patient characteristics, OPKO4K score and the addition of the ExoDX Prostate Cancer Test, and d baseline patient characteristics, OPKO 4K score, ExoDX Prostate Cancer Test and MP-MRI results
See this image and copyright information in PMC

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