Status:

RECRUITING

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

Lead Sponsor:

Endeavor Health

Collaborating Sponsors:

Northwestern University

Johns Hopkins University

Conditions:

Prostate Cancer

Eligibility:

MALE

40-69 years

Brief Summary

Condition: Prostate cancer Intervention: Biopsy and inherited risk assessment

Detailed Description

Inherited genetic changes, including rare pathogenic mutations (RPMs) in several major genes and single nucleotide polymorphisms (SNPs)-based genetic risk scores (GRS) have been consistently associate...

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.

Key Trial Info

Start Date :

December 13 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 13 2025

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT05295407

Start Date

December 13 2021

End Date

December 13 2025

Last Update

March 27 2024

Active Locations (1)

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1

NorthShore University HealthSystem

Evanston, Illinois, United States, 60626