Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 35 Years and 70 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Observational Patients 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.
  • Other: Non-Interventional Study
    Non-interventional study
    Other names:
    • Non-Interventional Observational Study
    • Noninterventional (Observational) Study

Recruiting Locations

University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
Contact:
Cancer AnswerLine
800-865-1125
CancerAnswerLine@med.umich.edu

More Details

Status
Recruiting
Sponsor
University of Michigan Rogel Cancer Center

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.