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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07645391

Enrollment

200

Registered

2026-06-12

Start date

2017-01-01

Completion date

2030-01-01

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Carcinoma

Brief summary

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.

Interventions

OTHERNon-Interventional Study

Non-interventional study

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

35 Years to 70 Years

Healthy volunteers

Inclusion criteria

* \* 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 criteria

* \* Anuria * Prior diagnosis or treatment for PCa * Failure to provide informed consent * Life expectancy \< 5 years

Design outcomes

Primary

Measure	Time frame	Description
Predictors of any HG PCa	At 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.

Countries

United States

Contacts

CONTACTCancer AnswerLine

CancerAnswerLine@med.umich.edu1-800-865-1125

PRINCIPAL_INVESTIGATORTodd M Morgan, MD

University of Michigan Rogel Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026