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Recruiting NCT07645391

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

— Observational Prostate Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Interventional Study.
Who it may be relevant to
Registry conditions: Prostate Carcinoma. Basic parameters: 35 years — 70 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Other Non-Interventional Study
    Non-interventional study

Primary outcome measures

  • Predictors of any HG PCa [Time frame: At 5-years follow up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Michigan Rogel Cancer Center — Ann Arbor

Identifiers

NCT: NCT07645391 · HUM00117711 · NCI-2025-07202 · HUM00117711 · P50CA186786

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗