BURLINGTON, Mass., Nov. 6, 2024 -- Broad Clinical Labs (BCL) and the Genomes2Veterans (G2V) Research Program announced today that the Department of Veterans Affairs' (VA)-funded Prostate Cancer, Genetic Risk, and Equitable Screening Study (ProGRESS) clinical trial will use BCL's Blended Genome-Exome (BGE) assay and analytical and interpretative pipelines to return genomic risk for prostate cancer to Veteran(s) who enroll in the trial, which has now started recruitment.
As healthcare shifts toward more personalized approaches, understanding individual risk is crucial for disease prevention. By leveraging biobank-linked healthcare systems like Veterans Affairs' Million Veteran Program (MVP), researchers developed a new genomic risk model for prostate cancer called Prostate CAncer integrated Risk Evaluation (P-CARE). The P-CARE model was developed using data from 585,418 male MVP participants, including 101,920 who identify as Black or African American. It combines genetic scores, family history, and genetic background to provide tailored risk assessments for prostate cancer. To ensure its accuracy, the model was validated in external datasets including those of the Prostate Cancer Association Group to Investigate Cancer Associated Alterations in the Genome (PRACTICAL) Consortium and from the NIH's All of Us Research Program. The model is now being used in the ProGRESS clinical trial of precision prostate cancer screening.
According to a study from the group, released this week as a preprint and presented at the American Society of Human Genetics national meeting, the P-CARE model describes a clinically important risk gradient for prostate cancer. For participants with high P-CARE scores (in the top 20%), the likelihood of developing prostate cancer was significantly increased. For example, in the MVP group, the risk of any prostate cancer was 2.75 times higher, while the risk for metastatic disease was 2.78 times greater, and the risk of fatal prostate cancer was 2.59 times higher compared to those with median scores. Among high-risk individuals, nearly 48% were expected to develop prostate cancer by age 90, compared to only 14% in the low-risk group. The ProGRESS trial is now testing whether this type of information allows healthcare providers to make better screening recommendations for men at lower and higher risk of disease.
"Biobank-linked healthcare systems like Veterans Affairs give us a unique opportunity to learn from existing patient data, develop better models, and deliver new paradigms of preventive care to patients," said Jason Vassy, MD, MPH, MS clinician-investigator at Veterans Affairs Boston Healthcare System and lead author on the study. "Veteran(s) we are now enrolling into the ProGRESS trial will help us understand the potential impact of precision prostate cancer screening on health outcomes."
"We are so proud to support this important study with G2V and Veterans Affairs," said Niall Lennon, PhD, CSO, and Chair of Broad Clinical Labs. "This trial leverages the power of our Blended Genome-Exome platform, where the imputed genome region can be used to compute polygenic scores and the exome region to look for monogenic risk factors. Our team is delighted to have worked with the team at Veterans Affairs to validate and launch this new pipeline and we look forward to delivering results to participants very soon."
The rollout of the ProGRESS trial highlights how biobank-linked healthcare systems can quickly turn research into real-world evidence-generating activities. Veteran(s) between the ages of 55-69, who are in receipt of regular Veterans Affairs care, and who are without a personal history of prostate cancer are eligible to enroll in the study (more information can be found at ClinicalTrials.gov by searching for Trial ID NCT05926102).
About Broad Clinical Labs:
Broad Clinical Laboratories was founded in 2013 as a subsidiary of Broad Institute of MIT and Harvard to accelerate the world toward a better understanding, diagnosis, and treatment of disease by pursuing projects, developing products, and driving adoption of cutting-edge 'omics technologies and novel molecular assays. Broad Clinical Labs is a leader in human whole genome sequencing, having sequenced over 680,000 genomes in service of its mission to accelerate the understanding and diagnosis of human disease.
About Genomes2Veterans:
Based at the VA Boston Healthcare System and spanning the larger ecosystem of Harvard Medical School, Mass General Brigham, Ariadne Labs, and the U.S. Department of Veterans Affairs, the Genomes2Veterans (G2V) Research Program conducts genomic and precision medicine implementation research to bring these new technologies to the healthcare of US Veterans.
For more information, please contact:
genomics@broadinstitute.org
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