Abstract LB-219: Clinical utility of a serum protein biomarker panel (FLNA, KRT19) in stratification of prostate cancer from benign prostate hyperplasia patients
Authors: Kiebish Michael A. , Tekmulla Poornima , Ravipaty Shobha , Wu Wenfang , Friss Tracey , Liao Chenchen , Klotz Allison , Andreazi Joe , Hutchins Elisabeth , Dobi Albert , Srivastava Shiv , Cullen Jennifer , Ali Amina , Freedland Stephen , Griffin Kagan , Laszlo Sandra , Petrovic Michele , Fleshner Neil , Garren Jeonifer , Rodrigues Leonardo , Kellog Mark D. , Akmaev Viatcheslav R. , Sarangarajan Rangaprasad , Narain Niven R. 
Published: August 2018

Abstract
Background: Prostate-specific antigen (PSA) based screening tests have been considered as a benchmark for PCa diagnosis (PSA &gt;4 ng/mL), however, in recent years their use has been widely debated due to various limitations. In particular, increased PSA levels are also observed in patients with benign prostatic hyperplasia (BPH) thus generating a false positive. These patients are often subjected to unnecessary prostate biopsies and have to endure both physical and mental anguish. Thus, there is a clear unmet need to develop molecular diagnostics that stratifies men with BPH from those that have PCa and prevent unwarranted prostate biopsies in symptomatic, DRE negative men. Here in, we demonstrate clinical utility of a validated biomarker panel (FLNA, KRT 19) in combination with age and prostate volume in stratifying BPH from PCa patients.
Methods: This study was conducted using retrospectively collected and clinically annotated serum samples from 203 BPH patients and 333 PCa patients with PSA values ranging from 4-10ng/mL. These samples included BPH patients with negative Digital Rectum Exam, single biopsy and repeat biopsies, and prostate cancer patients undergoing radical prostatectomy. Validated bioanalytical assays (FLNA ELISA, FLNA IPMRM and KRT19 ELISA) were used to quantitate the serum biomarkers. Regression models were built and compared for their ability to distinguish patients with BPH from those with PCa.
Results: Table 1: Summary of predictive power analysis of PCa panel (49 characters)
BERG TestPSAAUC0.80.54Sensitivity0.8n/aSpecificity0.62n/aPPV0.78n/aNPV0.65n/aOR (CI)6.67 (4.49,9.90)n/a
Conclusion: The data demonstrates that these PCa biomarkers in combination with age, and prostatic volume were significantly better than (0.8) PSA (0.54 AUC in this population) in identifying men with BPH rather than PCa thus preventing unnecessary biopsies for this population. Moreover, this panel may be used in clinical decision support to physicians to fill a clinical unmet need.
Citation Format: Michael A. Kiebish, Poornima Tekmulla, Shobha Ravipaty, Wenfang Wu, Tracey Friss, Chenchen Liao, Allison Klotz, Joe Andreazi, Elisabeth Hutchins, Albert Dobi, Shiv Srivastava, Jennifer Cullen, Amina Ali, Stephen Freedland, Kagan Griffin, Sandra Laszlo, Michele Petrovic, Neil Fleshner, Jeonifer Garren, Leonardo Rodrigues, Mark D. Kellog, Viatcheslav R. Akmaev, Rangaprasad Sarangarajan, Niven R. Narain. Clinical utility of a serum protein biomarker panel (FLNA, KRT19) in stratification of prostate cancer from benign prostate hyperplasia patients [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr LB-219.