Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07645391

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

35 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Cancer AnswerLine

CONTACT

[email protected]

800-865-1125

Todd M. Morgan, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Other names: Non-Interventional Observational Study, Noninterventional (Observational) Study

Primary outcomes

  1. Predictors of any HG PCa

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer AnswerLine

CONTACT

[email protected]

1-800-865-1125

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2017
Primary completion
2030
Study completion
2030
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.