Targeted Early Detection Program in Men at High Genetic Risk for Prostate Cancer
Part of paid clinical trials in Ann Arbor, Michigan.
- Sponsor
- University of Michigan Rogel Cancer Center
- Study ID
- NCT07645391
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- MALE
- Age
- 35 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Non-Interventional Study — OTHERNon-interventional study
Study Details
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.
Key Dates
- Start date
- Jan 1, 2017
- Status verified
- Jun 2026
- Primary completion
- Jan 31, 2030
- Completion
- Jan 31, 2030
Study Design
- Enrollment
- 200 participants (estimated)
Arms
- Arm: ObservationalPatients undergo urine and blood sample collection, provide family history of cancer and have their medical records reviewed throughout the study. Patients also undergo a digital rectal examination, complete a questionnaire and receive results of the PSA blood test and urine biomarker test. Patients with an elevated PSA level above 2.0 ng/ml (age 40-49) or 2.5 ng/ml (age 50-70) or abnormal urine test will be referred for an ultrasound-guided biopsy of the prostate gland.
Primary Outcome Measure
Predictors of any HG PCa [ Time Frame: At 5-years follow up ]
Central Contacts
- Cancer AnswerLine1-800-865-1125
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | Todd M. Morgan, MD (PRINCIPAL_INVESTIGATOR) |
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