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Prostate Cancer Genetic Risk Evaluation and Screening Study

This study is looking at men who have a higher genetic risk for prostate cancer, either due to specific gene changes (like in BRCA1, BRCA2, or ATM genes), a family history of prostate cancer, or being of Black/African ancestry. The goal is to understand how prostate cancer develops in these men and to see if enhanced screening with a physical exam (digital rectal exam), prostate-specific antigen (PSA) blood tests, and multiparametric MRI (magnetic resonance imaging) of the prostate can help find aggressive cancers earlier. Researchers hope to learn more about how these genetic changes affect prostate cancer risk and potentially discover new genetic risk factors. You can join if you are a man between 35 and 74 years old, have no known prostate cancer, and are expected to live more than 10 years.

Study design
This is an observational study with a planned enrollment of 400 men. It is designed to observe and collect data without assigning specific treatments.
What's involved
Participants will undergo a physical exam (digital rectal exam), prostate-specific antigen (PSA) blood tests, and multiparametric MRI of the prostate. The study will follow participants from enrollment until a prostate cancer diagnosis or until they reach 75 years of age.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the date of enrollment until the date of prostate cancer diagnosis or until they reach 75 years of age, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05129605

Prostate Cancer Genetic Risk Evaluation and Screening Study

Recruiting
Not specifiedAges 35–74Observational
Massachusetts General Hospital
~400 participants
Updated 2024-10-09 on ClinicalTrials.gov
What's tested:Prostate cancer screening

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnosis of prostate cancer
Measured over From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first

Conditions

Prostatic Neoplasm
Prostate Cancer
BRCA2 Mutation
BRCA1 Mutation
ATM Gene Mutation
MMR Mutation
Lynch Syndrome
Genetic Predisposition to Disease

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Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Keyan Salari, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Olympia Price
[email protected]
857-238-3838
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Men 35-74 years old
No known diagnosis of prostate cancer
Life expectancy \>10 years
Meet cohort A, B, or C criteria
Cohort A: Documented pathogenic or likely pathogenic germline genetic mutation in a prostate cancer risk gene from a CLIA-certified laboratory (ATM, ATR, BRCA1, BRCA2, BRIP1, CHEK2, EPCAM, FANCA, GEN1, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D, TP53)
Cohort B: A strong family history suggestive of high genetic risk for prostate cancer with negative clinical genetic testing
Cohort C: Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry

Exclusion

Prior diagnosis or treatment of prostate cancer
Inability to undergo prostate MRI
Inability to receive MRI contrast agent

What this trial measures

  • Diagnosis of prostate cancerFrom date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first

    Diagnosis of overall and clinically significant (grade group 2 or higher) prostate cancer