NCT07645391
Targeted Early Detection Program in Men at High Genetic Risk for Prostate Cancer
Recruiting
Not specifiedAges 35–70ObservationalUniversity of Michigan Rogel Cancer CenterInvestigator-initiated
~200 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Non-Interventional Study
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Predictors of any HG PCa
Measured over At 5-years follow up
Conditions
Where it's being run
1 sites across 1 statesMichigan1
Study leadership
- Todd M Morgan, MD · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
\* Age 35-70 years
Capable of providing informed consent
Prognosis of \> 5 years if affected by another cancer
Patients need one to meet at least one of the following high genetic risk categories:
Known PCa-related mutations: BRCA 1 and 2, Lynch syndrome, or p53
Carrier of mutation in a suspected PCa-related gene: e.g., ATM, PALB2, CHEK2, RAD51D, ATR, NBN, GEN1, RAD51C, MRE11A, BRIP1, FAM175A, HOXB13
Obligate carriers of the above mutations (e.g. their sisters/daughters have known mutations)
Men with any family history of above mutation
Family history of breast, prostate, or ovarian cancer in at least 2 individuals, or in 1 individual diagnosed before age 50
Exclusion
\* Anuria
Prior diagnosis or treatment for PCa
Failure to provide informed consent
Life expectancy \< 5 years
What this trial measures
- Predictors of any HG PCaAt 5-years follow up
Descriptive statistics, parametric and non-parametric statistical tests will be used to summarize the clinical variables. Will estimate the prevalence and incidence. Will fit two statistical models with cross-validation to evaluate the performance characteristics (Brier score, area under curve, sensitivity, specificity, positive and negative predictive values) of SelectMDx in predicting i) HG PCa and ii) any PCa.