The Department of Veterans Affairs launched the Prostate Cancer, Genetic Risk, and Equitable Screening Study, known as ProGRESS, to determine whether genetic testing can improve prostate cancer screening while reducing the risks of overdiagnosis. According to Department of Veterans Affairs announcements, the trial expects to enroll a diverse sample of approximately 5,000 Veterans nationwide between the ages of 55 and 69 who have not previously had a prostate biopsy or MRI and who have not been diagnosed with prostate cancer.
How the ProGRESS Trial Uses Genetic Risk Models
The study evaluates participants using the Prostate CAncer integrated Risk Evaluation (P-CARE) model, which was developed using data from the Million Veteran Program. According to Department of Veterans Affairs documentation, the P-CARE model incorporates 601 genetic variants, genetic ancestry, and patient-reported family history of prostate cancer to estimate an individual’s risk of developing metastatic prostate cancer. Enrolled participants provide a one-time saliva sample via a collection kit delivered directly to their homes. Broad Clinical Labs extracts DNA and performs genetic analysis from these samples to generate individual risk reports.
Randomization and Precision Screening Intervention
Once laboratory analysis is complete, participants who provide a viable biospecimen are randomized into one of two study groups. According to trial protocols, participants in the precision screening arm receive their P-CARE assessment and recommendations about prostate cancer screening, which are shared with both the participant and their primary care provider. A genetic counselor is available to discuss individual result. The control group receives the standard of care. Researchers aim to discover if precision screening targets individuals at highest risk of developing prostate cancer while safely deferring screening for low-risk individuals.
Addressing Overdiagnosis in Prostate Screening
Traditional prostate-specific antigen (PSA) testing modestly reduces prostate cancer related deaths but also increases the risks associated with overdiagnosis and overtreatment, according to Department of Veterans Affairs background data. Because of these associated harms, there is no universal prostate cancer screening recommendation from the United States Preventive Services Task Force or the VHA National Center for Health Promotion and Disease Prevention. The ProGRESS trial seeks to establish whether incorporating genetic risk stratification can improve prostate cancer screening for Veterans.
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