About this trial
This study evaluates urinary biomarkers and PSA to help determine the best approach to early detection of prostate cancer in patients with an elevated familial risk.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
* Age 35-70 years
Capable of providing informed consent
Prognosis of > 5 years if affected by another cancer
Known PCa-related mutations: BRCA 1 and 2, Lynch syndrome, or p53
Disqualifiers
* Anuria
Prior diagnosis or treatment for PCa
Failure to provide informed consent
Life expectancy < 5 years
Trial population
Men at high risk for prostate cancer recruited through University of Michigan Comprehensive Cancer Center
Trial design
Cohort
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-interventional study
Treatment groups
Trial outcomes
Primary outcomes
Predictors of any HG PCa
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.
Sponsors and contacts
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University of Michigan Rogel Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator