Targeted Early Detection for Men at High Genetic Risk for Prostate Cancer
Official title: Targeted Early Detection Program in Men at High Genetic Risk for Prostate Cancer
Run by University of Michigan Rogel Cancer Center · NCT07645391 · Data updated 2026-11-12
This study tests urinary biomarkers and PSA to see if they can improve early detection for men with a strong family or genetic risk for prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 35 Years to 70 Years |
| Sex | Men only |
| Enrollment | 200 (estimated) |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Status | Recruiting |
| Started | January 1, 2017 |
| Main results expected | January 2030 |
| Study ends | January 2030 |
| Registry record updated | June 12, 2026 |
| Trial ID | NCT07645391 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men aged 35-70 with known PCa-related genetic mutations or a strong family history of prostate, breast, or ovarian cancer, and with a predicted life expectancy over 5 years.
✕Probably not a fit
Men without elevated genetic risk or familial history, or those with a prior prostate cancer diagnosis, may not benefit from this screening-focused program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational, non-interventional program that follows men aged 35-70 with high genetic or familial risk for prostate cancer. Researchers will collect and analyze urinary biomarkers and PSA results to see how they correlate with early detection signals. The goal is to identify reliable markers that could prompt earlier or more targeted screening in this high-risk population.
Why it matters
Potential benefit: If successful, it could refine how high-risk men are screened for prostate cancer, potentially enabling earlier detection.
How similar studies have gone: Previous work in risk-based screening has shown promise for targeted approaches, though the use of urinary biomarkers in this exact high-risk group is still being explored.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States Recruiting
Study contacts
- Principal investigator: Todd M Morgan, MD — University of Michigan Rogel Cancer Center
- Study coordinator: Cancer AnswerLine
- Email: CancerAnswerLine@med.umich.edu
- Phone: 1-800-865-1125
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.