ASCO 2018: The GENTleMEN Study: Genetic Testing for Men with Metastatic Prostate Cancer in Washington State and Beyond

Chicago, IL ( It is known that 10% of metastatic prostate cancer patients harbor germline DNA repair gene mutations.[1] These mutations (e.g. BRCA2, BRCA1) may have important implications for treatment, clinical trial selection, and family members counseling.  According to the NCCN guidelines from 2018 for prostate cancer, there is a clear recommendation for germline testing for all men with metastatic and high/very high risk clinically localized prostate cancer.[2] Despite the importance of this testing, significant limitations exist which include lack of awareness by the patient/physician, limited access to genetics services, variable insurance coverage, and associated high out-of-pocket costs.

The authors of this study aimed to assess the feasibility and patients’ acceptance of a web-based model of offering germline genetic testing to all men with metastatic prostate cancer (MPC) in Washington state (currently open across the US).

Patients included in the study are older than 18, with MPC and willingness to undergo germline genetic testing. This is a prospective, observational study with 2000 patients planned to be recruited (NCT03503097). The trial schema is shown in figure 1. The patient survey includes demographics, family cancer history, validated instruments including GAD7, PHQ9, Cancer distress, risk perception, decision conflict, knowledge and concern with genetic testing. Germline testing is performed on a saliva sample via Color Genomics 30 gene targeted panel of cancer predisposition genes ( 

Speaking to the authors, they emphasize that germline genetic testing is increasingly being relevant to men with MPC and their families. This study is investigating a new model of delivering genetic testing to supplement existing genetics services and remove any potential limitations and barriers to genetic testing.

Figure 1 – Trial schema:
GENTleMEN study trial schema

1. Pritchard et al. NEJM 2016
2. NCCN 2018 guidelines: Prostate; genetic, family high-risk assessment: breast and ovarian

Presented by: Heather H. Cheng, University of Washington, Seattle, WA

Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre, Twitter: @GoldbergHanan, at the 2018 ASCO Annual Meeting - June 1-5, 2018 – Chicago, IL USA
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