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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT07645391
Status
Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
35 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Non-Interventional Study — OTHER
    Non-interventional study

Study Details

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.

Key Dates

Start date
Jan 1, 2017
Status verified
Jun 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Predictors of any HG PCa [ Time Frame: At 5-years follow up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109
Cancer AnswerLine
800-865-1125
Todd M. Morgan, MD (PRINCIPAL_INVESTIGATOR)

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