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Development and Validation of an 18-Gene Urine Test for High-Grade Prostate Cancer

Development and Validation of an 18-Gene Urine Test for High-Grade Prostate Cancer

2024-04-18 | Jeffrey J. Tosoian, MD, MPH; Yuping Zhang, PhD; Lanbo Xiao, PhD; Cassie Xie, MS; Nathan L. Samora, MD; Yashar S. Niknafs, PhD; Zoey Chopra, MA; Javed Siddiqui, MS; Heng Zheng, MD; Grace Herron, BA; Neil Vaishampayan, BS; Hunter S. Robinson, MD; Kumaran Arivoli, BS; Bruce J. Trock, PhD; Ashley E. Ross, MD, PhD; Todd M. Morgan, MD; Ganesh S. Palapattu, MD; Simpa S. Salami, MD, MPH; Lakshmi P. Kunju, MD; Scott A. Tomlins, MD, PhD; Lori J. Sokoll, PhD; Daniel W. Chan, PhD; Sudhir Srivastava, PhD; Ziding Feng, PhD; Martin G. Sanda, MD; Yingye Zheng, PhD; John T. Wei, MD; Arul M. Chinnaiyan, MD, PhD, for the EDRN-PCAS Study Group
This study aimed to develop and validate a 18-gene urinary test for high-grade prostate cancer (GG2 or greater) to improve upon the current biomarker tests. The researchers identified 54 markers of prostate cancer, including 17 markers uniquely overexpressed by high-grade cancers, through RNA sequencing analysis. These markers were modeled into a new urinary test, MyProstateScore 2.0 (MPS2), which was then validated in a prospective National Cancer Institute trial cohort. The validation results showed that the MPS2 model had a higher diagnostic accuracy compared to existing biomarker tests, with an area under the receiver operating characteristic curve (AUC) of 0.81. At a 95% sensitivity threshold for high-grade cancer, the MPS2 model reduced unnecessary biopsies by 35% to 51% compared to other tests. The study concluded that the new 18-gene urinary test could safely avoid unnecessary additional testing while maintaining high sensitivity for high-grade cancers, reducing the potential harms of prostate cancer screening while preserving its long-term benefits.This study aimed to develop and validate a 18-gene urinary test for high-grade prostate cancer (GG2 or greater) to improve upon the current biomarker tests. The researchers identified 54 markers of prostate cancer, including 17 markers uniquely overexpressed by high-grade cancers, through RNA sequencing analysis. These markers were modeled into a new urinary test, MyProstateScore 2.0 (MPS2), which was then validated in a prospective National Cancer Institute trial cohort. The validation results showed that the MPS2 model had a higher diagnostic accuracy compared to existing biomarker tests, with an area under the receiver operating characteristic curve (AUC) of 0.81. At a 95% sensitivity threshold for high-grade cancer, the MPS2 model reduced unnecessary biopsies by 35% to 51% compared to other tests. The study concluded that the new 18-gene urinary test could safely avoid unnecessary additional testing while maintaining high sensitivity for high-grade cancers, reducing the potential harms of prostate cancer screening while preserving its long-term benefits.
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