Recruiting

Genetic RiskThe Prostate Cancer, Genetic Risk, and Equitable Screening Study (ProGRESS)

Sponsor:

VA Office of Research and Development

Code:

NCT05926102

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 55 - 69

Healthy Volunteers: Accepted

Interventions

Precision screening intervention

Usual care

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Study ID

NCT05926102

Start date

Feb 1, 2024

Status verified date

Jan, 2026

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Sep 30, 2029

Anticipated

Eligibility Criteria

Sex: Male

Age: 55 - 69

Healthy Volunteers: Accepted

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

Study Design

Enrollment

5000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Precision screening intervention

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.

experimental: Usual care

Usual care in this study includes receipt of a brief brochure about shared decision-making in prostate cancer screening.

Interventions

Precision screening intervention

Usual care

Usual care in this study includes receipt of a brief brochure about shared decision-making in prostate cancer screening.

Primary outcome measure

Diagnosis of clinically significant prostate cancer [ Time Frame: 7 years ]
Negative prostate biopsy [ Time Frame: 7 years ]

Central Contacts and Locations

Central contacts

Charles A Brunette, PhD

(857) 364-6324 charles.brunette@va.gov

Locations

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Recruiting

Boston, Massachusetts, United States, 02130-4817

Contacts

Charles A Brunette, PhD

857-364-6324 charles.brunette@va.gov

Principal Investigator:

Jason L Vassy, MD MPH

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Keywords

early detection of cancer
prostatic neoplasms
polygenic risk scores
family health history

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-01-13.