The Prostate Cancer, Genetic Risk, and Equitable Screening Study (ProGRESS): A Pragmatic Trial of Precision Prostate Cancer Screening

ONCA-021-22F

Prostate cancer is the most common non-skin cancer among Veterans and the second leading cause of male cancer death. Current methods of screening men for prostate cancer are inaccurate and cannot identify which men do not have prostate cancer or have low-grade cases that will not cause harm and which men have significant prostate cancer needing treatment. False-positive screening tests can result in unnecessary prostate biopsies for men who do not need them. However, new genetic testing might help identify which men are at highest risk for prostate cancer. This study will examine whether a genetic test helps identify men at risk for significant prostate cancer while helping men who are at low risk for prostate cancer avoid unnecessary biopsies. If this genetic test proves beneficial, it will improve the way that healthcare providers screen male Veterans for prostate cancer.

2024-02-01

2029-09-30

2030-09-30

Recruiting

5000

Inclusion Criteria: * baseline age 55-69 years * receipt of regular VA care * Veteran status Exclusion Criteria: * personal history of prostate cancer * prior prostate biopsy, prostatectomy, or prostate MRI * known carrier status of rare variant associated with cancer syndrome

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Enrolled participants will be randomly allocated to receive either the precision screening intervention or usual care. The precision screening intervention will consist of an interpreted prostate cancer genetic risk assessment (GRA) report, provided to the participant along with tailored prostate cancer screening recommendations and, in cases of high genetic risk, genetic counseling. The risk report and supporting educational materials will also be provided to the participant's primary care provider. Usual care in this study includes receipt of a brief brochure about shared decision-making in prostate cancer screening.", 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 5000, 'type': 'ESTIMATED'}}

2024-02-15