Genetic Testing for Prostate Cancer Screening (ProGRESS Trial)

N/A

Recruiting

Led By Jason L Vassy, MD MPH

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a genetic test can help identify which men are at highest risk for prostate cancer and who don't need biopsies. It could improve how male Veterans are screened for prostate cancer.

Who is the study for?

The ProGRESS study is for male Veterans aged 55-69 who regularly receive care from the VA. It's designed to help those at risk of prostate cancer and aims to reduce unnecessary biopsies in men with low risk by using genetic testing.

What is being tested?

This trial tests a precision screening intervention based on genetic testing against usual care methods. The goal is to see if this new approach more accurately identifies men at high or low risk for significant prostate cancer.

What are the potential side effects?

Since the intervention involves genetic testing rather than medication, traditional side effects are not applicable. However, there may be some psychological impact or anxiety associated with learning about one's genetic risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diagnosis of clinically significant prostate cancer

Negative prostate biopsy

Secondary study objectives

Diagnosis of prostate cancer

PSA testing

Prostate MRI

+3 more

Other study objectives

Acceptability of the precision prostate cancer screening intervention

Adherence to precision cancer screening recommendations

Rare pathogenic/likely pathogenic variants

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual careExperimental Treatment1 Intervention

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

Group II: Precision screening interventionExperimental Treatment2 Interventions

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.

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