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Noninvasive Detection of AR-FL/AR-V7 as a Predictive Biomarker for Therapeutic Resistance in Men with Metastatic Castration-Resistant Prostate Cancer

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Technical Report,30 Sep 2017,29 Sep 2018

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Johns Hopkins University Baltimore United States

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Understanding primary and acquired resistance to abiraterone and enzalutamide, and developing analytically validated and clinically qualified predictive biomarkers, remains a critically important unmet medical need. We propose non-invasive detection of full-length androgen receptor AR-FL and the androgen receptor splice variant 7 AR-V7 AR-FLAR-V7 as a predictive biomarker for therapeutic resistance in men with metastatic castration-resistant prostate cancer. Using a laboratory-developed, RNA-based assay modified from a commercially available circulating tumor cell CTC detection platform, we have developed standard operating procedures and performed extensive internal validation and quality control studies to determine its feasibility for detection of AR-FLAR-V7 in blood samples. Although our recent studies show data supporting this predictive biomarker, analytical validation is required prior to clinical use, and a large-scale, multi-institutional study is needed to further establish clinical utility. The overall objective of the project is to enable precision therapy of metastatic castration-resistant prostate cancer by developing non-invasive tests for the AR-FLAR-V7.

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  • Medicine and Medical Research

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