RecruitingNot Applicable

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

United States200 participantsStarted 2017-01-01

Plain-language 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.

Who can participate

Age range

35 Years – 70 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Predictors of any HG PCa

Timeframe: At 5-years follow up

Trial details

NCT IDNCT07645391

SponsorUniversity of Michigan Rogel Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-01

Contact for this trial

Cancer AnswerLine

1-800-865-1125 CancerAnswerLine@med.umich.edu

View on ClinicalTrials.gov More Prostate Carcinoma trials