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Clinical trial Recruiting at 1 site Observational Ages 40 to 69 Men only

Assessing inherited risk for predicting prostate cancer from biopsies

Official title: Observational and Prospective Study on the Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy (GenBx)

Run by Endeavor Health · NCT05295407 · Data updated 2026-11-12

This study is testing if looking at inherited genetic risks can help doctors better predict prostate cancer outcomes from biopsies in patients of different races.

Quick facts

Study typeObservational
Ages40 Years to 69 Years
SexMen only
Enrollment1000 (estimated)
SponsorEndeavor Health
Academic / other
Locations1 site (Evanston, Illinois)
StatusRecruiting
StartedDecember 13, 2021
Main results expectedDecember 13, 2026
Study endsDecember 13, 2027
Registry record updatedFebruary 27, 2026
Trial IDNCT05295407 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men aged 40 to 69 years from diverse ethnic backgrounds undergoing prostate biopsy with PSA levels between 2.5-10 ng/mL.

Probably not a fit

Patients with a previous diagnosis of prostate cancer or those outside the specified ethnicities and PSA range may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of inherited genetic risk assessments in predicting prostate cancer outcomes from biopsies. It focuses on identifying rare pathogenic mutations and genetic risk scores associated with prostate cancer risk among multi-racial patients. By analyzing data from patients undergoing prostate biopsy, the study seeks to confirm the clinical utility of these genetic assessments in improving diagnostic accuracy. The findings could influence clinical guidelines regarding prostate cancer screening and biopsy decision-making.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of prostate cancer diagnoses and improve patient outcomes through tailored screening strategies.

How similar studies have gone: Previous studies have shown promising results in using genetic assessments for prostate cancer risk prediction, suggesting this approach has potential clinical utility.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* Previous diagnosis of prostate cancer.
* Ethnicity outside the inclusion criterion (including mixed ethnicity).
* Any prior PSA test result outside the range of inclusion criterion.

Where it's running

  • NorthShore University HealthSystem
    Evanston, Illinois, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.