Targeted Early Detection Program in Men at High Genetic Risk for Prostate Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age35-70
SponsorUniversity of Michigan Rogel Cancer Center

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 volunteers

Qualifiers

* 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non-Interventional Study

    Other intervention

    Non-interventional study

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Observational1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At 5-years follow up

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan Rogel Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator