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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
VA Office of Research and Development
Study ID
NCT05926102
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
55 Years - 69 Years
Healthy Volunteers
Accepted

Interventions

  • Precision screening intervention — GENETIC
    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.
  • Usual care — OTHER
    Usual care in this study includes receipt of a brief brochure about shared decision-making in prostate cancer screening.

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
Jan 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2030

Study Design

Enrollment
5,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABostonMassachusetts02130-4817
Charles A Brunette, PhD
[email protected]
857-364-6324
Jason L Vassy, MD MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA· Boston, MA

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