Observational Study of Inherited Risk for Prostate Cancer Detection

This study is looking at how inherited genetic factors, specifically rare pathogenic mutations (RPMs) and genetic risk scores (GRS), relate to finding prostate cancer during a prostate biopsy. Researchers want to see if these genetic assessments can help identify men who are more likely to have prostate cancer detected. You might be able to join if you are a man between 40 and 69 years old, are undergoing a prostate biopsy, and have a PSA (prostate-specific antigen) level between 2.5-10 ng/mL. You also need to be of Caucasian, African American, East Asian, or Latino ethnicity. The main goal is to see if these genetic assessments are linked to a prostate cancer diagnosis from your biopsy report, with results being looked at over 4 years. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will observe and collect information without providing specific treatments. It aims to include 1000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your prostate cancer diagnosis from the biopsy report will be measured at 4 years.

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NCT05295407

Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy

Recruiting
Not specifiedAges 40–69Observational
Endeavor Health
~1,000 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:Genetic Assessment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prostate Cancer Diagnosis from Prostate Biopsy Report
Measured over 4 years
Prostate Cancer
1 sites across 1 states
Illinois1
  • Jianfeng Xu, MD, Dr.PH · PRINCIPAL_INVESTIGATOR · Endeavor Health

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Eligibility criteria

Inclusion

Consecutive patients undergoing prostate biopsy for detection of prostate cancer
Aged 40 to 69 years
Four ethnicity groups (Caucasian, African Americans, East Asians, Latinos)
PSA between 2.5-10 ng/mL

Exclusion

Previous diagnosis of prostate cancer.
Ethnicity outside the inclusion criterion (including mixed ethnicity).
Any prior PSA test result outside the range of inclusion criterion.
  • Prostate Cancer Diagnosis from Prostate Biopsy Report4 years

    The primary outcome measure is prostate cancer diagnosis from the prostate biopsy report. The primary goal is to compare prostate cancer detection rate in patients of three inherited risk groups (high-risk, intermediate-risk, and low-risk).