A 17-Gene Genomic Prostate Score Assay Provides Independent Information on Adverse Pathology in the Setting of Combined Multiparametric Magnetic Resonance Imaging Fusion Targeted and Systematic Prostate Biopsy

Amirali Salmasi; Jonathan Said; Alan W Shindel; Pooria Khoshnoodi; Ely R Felker; Anthony E Sisk Jr; Tristan Grogan; Debbie McCullough; John Bennett; Helen Bailey; H Jeffrey Lawrence; David A Elashoff; Leonard S Marks; Steven S Raman; Phillip G Febbo; Robert E Reiter

doi:10.1016/j.juro.2018.03.004

A 17-Gene Genomic Prostate Score Assay Provides Independent Information on Adverse Pathology in the Setting of Combined Multiparametric Magnetic Resonance Imaging Fusion Targeted and Systematic Prostate Biopsy

J Urol. 2018 Sep;200(3):564-572. doi: 10.1016/j.juro.2018.03.004. Epub 2018 Mar 7.

Authors

Amirali Salmasi¹, Jonathan Said², Alan W Shindel³, Pooria Khoshnoodi⁴, Ely R Felker⁴, Anthony E Sisk Jr², Tristan Grogan⁵, Debbie McCullough³, John Bennett³, Helen Bailey³, H Jeffrey Lawrence³, David A Elashoff⁵, Leonard S Marks¹, Steven S Raman⁶, Phillip G Febbo³, Robert E Reiter⁷

Affiliations

¹ Institute of Urologic Oncology, Department of Urology, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California.
² Department of Pathology, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California.
³ Genomic Health, Inc., Redwood City, California.
⁴ Department of Radiology, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California.
⁵ Department of Medicine Statistics Core, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California.
⁶ Institute of Urologic Oncology, Department of Urology, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California; Department of Radiology, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California.
⁷ Institute of Urologic Oncology, Department of Urology, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California; Jonsson Comprehensive Cancer Center, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles. Electronic address: RReiter@mednet.ucla.edu.

PMID: 29524506
DOI: 10.1016/j.juro.2018.03.004

Abstract

Purpose: Multiparametric magnetic resonance imaging and biopsy based molecular tests such as the 17-gene Oncotype DX® Genomic Prostate Score™ assay are increasingly performed to improve risk stratification in men with clinically localized prostate cancer. The prostate score assay was previously shown to be a significant independent predictor of adverse pathology findings at radical prostatectomy in men diagnosed by systematic biopsies only. Therefore, we investigated the ability of the prostate score assay to predict adverse pathology findings in the setting of magnetic resonance imaging guided prostate biopsy.

Materials and methods: We identified men diagnosed with NCCN® (National Comprehensive Cancer Network®) very low, low or intermediate risk prostate cancer who underwent simultaneous multiparametric magnetic resonance imaging fusion targeted and systematic prostate biopsy with subsequent radical prostatectomy within 6 months. Prostate score assay testing was performed on biopsy tissue with the highest Gleason score. The primary outcome of the study was adverse pathology findings, defined as Gleason score 4 + 3 or greater disease and/or pT3+ at radical prostatectomy. Independent predictors of adverse pathology findings were determined in a multivariable model to adjust for clinical parameters.

Results: A total of 134 men were eligible for primary analysis. On univariable analysis the UCLA score, magnetic resonance imaging, prostate score assay results and biopsy Gleason score were significant predictors of adverse pathology findings. After multivariable adjustment prostate score assay values remained a significant predictor of adverse pathology results (prostate score assay per 20 U OR 3.28, 95% CI 1.74-6.62, p <0.001). A wide and overlapping distribution of prostate score assay results was seen across PI-RADS® (Prostate Imaging Reporting and Data System) version 2 scores.

Conclusions: The prostate score assay result is an independent predictor of adverse pathology findings in patients who were diagnosed with very low, low or intermediate risk prostate cancer in the setting of multiparametric magnetic resonance imaging fusion prostate biopsy. This assay can be useful as an independent technology or an adjunct technology to multiparametric magnetic resonance imaging to individualize risk stratification of low and intermediate risk prostate cancer.

Keywords: biopsy; genomics; magnetic resonance imaging; pathology; prostatic neoplasms.

MeSH terms

Genomics
Humans
Image-Guided Biopsy
Magnetic Resonance Imaging / methods
Male
Middle Aged
Neoplasm Grading
Predictive Value of Tests
Prostatic Neoplasms / diagnostic imaging
Prostatic Neoplasms / genetics*
Prostatic Neoplasms / pathology*
Retrospective Studies
Risk Assessment