ASCO GU 2018: An Observational Study Profiling Biospecimens from 10,000 Metastatic Prostate Cancer Patients to Screen for Molecular Alterations

San Francisco, CA (UroToday.com) Despite recent success in development and use of targeted agents in patients with solid tumors, there is a paucity of such therapies approved for use in prostate cancer (PC). The authors presented this observational study performing next-generation sequencing (NGS) to men with metastatic PC, in an attempt to evaluate the proportion of patients available for targeted therapy clinical trials in metastatic PC. Furthermore, they aimed to assess the feasibility of using a large-scale NGS screening program to match patients for eligibility criteria in clinical trials.

Methods:

Using a virtual clinical trial model to maximize patient access and enrollment, this study is NGS to 10,000 men with metastatic PC (Mpc). Patients with histologically-documented mPC and surplus formalin-fixed paraffin-embedded tumor tissue are eligible for enrollment. Leftover archival tissue is submitted for NGS to Strata Oncology, a clinical laboratory improvement amendments (CLIA)-certified lab. The Strata NGS assay sequences DNA and RNA, and simultaneously detects a range of actionable genomic alterations including gene mutations, small insertions and deletions, copy number changes, and gene fusions in 87 cancer-related genes. Microsatellite instability status is determined via the number of length variant alleles observed in NGS sequencing data at several microsatellite loci. Test reports that will be presented to the clinician, will include all positive and negative variants detected, and information regarding potential matching therapeutic protocols. Clinical trial information: NCT03061305


Presented by: Won Kim, MD University of California, San Francisco, USA

Co Authors: Kat Kwiatkowski, Justin Brown, Dan R Rhodes, Scott A Tomlins, Felix Y Feng, Eric Jay Small; University of California San Francisco, San Francisco, CA; Strata Oncology, Ann Arbor, MI

Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre @GoldbergHanan at the 2018 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, February 8-10, 2018 - San Francisco, CA
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