Targeted Early Detection Program in Men at High Genetic Risk for Prostate Cancer
Recruiting · NCT07645391 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Michigan Rogel Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
Non-Interventional Study
What this trial is about
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.
Who can take part
Age range
35 Years to 70 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- University of Michigan Rogel Cancer Center - Ann Arbor, Michigan, United States