Targeted Early Detection Program in Men at High Genetic Risk for Prostate Cancer
About This Trial
- This study is testing whether using a simple urine test alongside a routine blood test can better detect prostate cancer at an early stage.
- It is open to men aged 35 to 70 who have an increased risk of developing the disease due to a strong family history of cancer or inherited gene changes.
- Before considering this trial, you should know that it is specifically designed for people who have never been diagnosed with or treated for prostate cancer.
- To join, you must also be able to provide urine samples and have an overall life expectancy of more than five years.
More Information
- 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 Enroll
- Age Range: 35 - 70 years
- Gender: Male
- Who This Trial is For: This study is testing whether using a simple urine test alongside a routine blood test can better detect prostate cancer at an early stage.
Study Details
- Start Date: January 1, 2017
- Lead Sponsor: University of Michigan Rogel Cancer Center
Full 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
Treatments
- Other: Non-Interventional Study