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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
35 Years to 70 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests signs in urine and PSA, a protein linked to the prostate, to help find prostate cancer early. It is for men ages 35–70 who have a higher risk because of gene changes or family history.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 35–70 years old and able to understand and agree to join the study.
  • If you have another cancer, be expected to live more than 5 years.
  • Meet at least one of the gene or family risk conditions listed below.
  • Have a known prostate cancer–linked gene change: BRCA1, BRCA2, a change linked to Lynch syndrome, or p53.
  • Have a gene change that may be linked to prostate cancer, such as ATM, PALB2, CHEK2, or HOXB13.
  • Be certain to carry one of these gene changes based on your family’s genes, even without your own test.
  • Have a family history of one of these gene changes.
  • Have at least 2 relatives with breast, prostate, or ovarian cancer, or 1 relative diagnosed before age 50.

Who can't join

  • Your body does not make urine.
  • You have been diagnosed with or treated for prostate cancer.
  • You do not give informed consent, meaning you agree to join after learning about the study.
  • You are expected to live less than 5 years.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MI