NCT07645391 Targeted Early Detection Program in Men at High Genetic Risk for Prostate Cancer
| NCT ID | NCT07645391 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan Rogel Cancer Center |
| Condition | Prostate Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2017-01-01 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2017-01-01 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Todd M Morgan, MD
PRINCIPAL INVESTIGATOR
University of Michigan Rogel Cancer Center
Frequently Asked Questions
Who can join the NCT07645391 clinical trial?
This trial is open to male participants only, aged 35 Years or older, up to 70 Years, studying Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07645391 currently recruiting?
Yes, NCT07645391 is actively recruiting participants. Contact the research team at CancerAnswerLine@med.umich.edu for enrollment information.
Where is the NCT07645391 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT07645391 clinical trial?
NCT07645391 is sponsored by University of Michigan Rogel Cancer Center. The principal investigator is Todd M Morgan, MD at University of Michigan Rogel Cancer Center. The trial plans to enroll 200 participants.