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January 8, 2025
By Joe Huggins
VA Research Communications
A large team of VA, academic, and industry researchers created a precision risk screening tool for prostate cancer that is now being tested – the Prostate Cancer, Genetic Risk & Equitable Screening Study (ProGRESS) is a randomized clinical trial that started accepting participants in November 2024.
Researchers developed a risk model for prostate cancer based on family history and a person’s genes that proved highly accurate in the initial test of a retrospective study on about 18,000 subjects’ health records. The test performed well across different groups of patients, including those of different races and ethnicities, beating the current one-size-fits-all approach by using individual risk prediction.
Now, the VA is testing the model in a live clinical setting. The trial’s goal is to recruit 5,000 male U.S. Veterans between the ages of 55 and 69 who have never had prostate cancer or a prostate biopsy. Participants will receive a saliva collection kit to collect their DNA. A partner lab will then analyze their saliva sample for genetic markers related to prostate cancer risk. Participants will be randomly assigned to either the standard prostate care group or the precision prostate cancer screening group to test the accuracy of the new screening tool.
The ProGRESS screening tool was created using data from almost 600,000 male Veterans in the VA Million Veteran Program (MVP). MVP is a VA biobank in which Veterans provide biological samples; grant access to their electronic health record; and complete surveys about family history, health behaviors, military and environmental exposures, and other health-related factors. MVP researchers can use this wealth of data to create prediction models based on a person’s individual genes for a variety of diseases. The Office of Research and Development (ORD) is working to demonstrate the clinical benefit of implementing these risk models in clinical care.
Since prostate cancer is one of the most inheritable cancers, using genomic data to predict risk had a high chance of success. Recent genomic discoveries have identified both rare and common genetic variations underlying much of this heritability.
Universal screening with a prostate-specific antigen test reduces prostate cancer mortality but can also over-diagnose prostate cancer and lead to unnecessary procedures and treatments. Each year, one in 200 men from 55 to 69 has a prostate biopsy in VA. Two-thirds of these are negative for prostate cancer, meaning that the current prostate test flagged them for an unnecessary biopsy.
In addition to avoiding unnecessary procedures by hopefully finding a more accurate screening approach, using individualized precision medicine for prostate cancer screening could also allow doctors to more closely monitor patients who have a higher risk. In the United States, Black men are more likely to be diagnosed with, and die from, prostate cancer.
Whereas one in every eight men will develop prostate cancer in his lifetime, on average, the rate for Black men specifically is one in six. This may be due to genetic, environmental, or social risks, including systemic racism and lack of access to medical screening and other health care. Prostate cancer guidelines highlight Black men as a group whose high risk deserves earlier screening. When caught early, 99% of men with prostate cancer live for at least five more years. If the current clinical trial proves the accuracy of this new screening tool, it could further address this health disparity.
To learn more and join the clinical trial, go to progress-study.org.
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