Recruiting

Inherited Risk Assessment

Sponsor:

Endeavor Health

Code:

NCT05295407

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40 - 69

Healthy Volunteers: Not accepted

Interventions

Genetic Assessment

Study Details

Brief summary:

Condition: Prostate cancer Intervention: Biopsy and inherited risk assessment

Conditions

Prostate Cancer

Study ID

NCT05295407

Start date

Dec 13, 2021

Status verified date

Feb, 2026

Completion date

Dec 13, 2027

Anticipated

Primary completion date

Dec 13, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 69

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Men 40-69 years old

Men with moderately-elevated PSA (2.5-10 ng/mL) undergoing prostate biopsy for detecting prostate cancer at NorthShore University HealthSystem, Northwestern University, or Johns Hopkins Hospital. The trial will not alter any clinical practice for diagnostic biopsy that includes state-of-the-art procedures (transperineal fusion biopsy, multiparametric MRI, and novel biomarkers).

Interventions

Genetic Assessment

The trial is to observe whether inherited risk, including rare pathogenic mutations (RPMs) in several major genes and SNPs-based genetic risk scores (GRS), is correlated with prostate cancer detection rate from diagnostic prostate biopsy.

Primary outcome measure

  • Prostate Cancer Diagnosis from Prostate Biopsy Report [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Annie Ashworth

2243647502aashworth@northshore.org

Locations

NorthShore University HealthSystem

Recruiting

Evanston, Illinois, United States, 60626

Contacts

Pooja Talaty

847-503-4280ptalaty@northshore.org

Malgorzata Antoniak

847-570-2112mantoniak@northshore.org

Principal Investigator:

Jianfeng Xu, MD, DrPH

More Information

Sponsor

Endeavor Health

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Prostate biopsy
  • prostate cancer
  • inherited risk assessment
  • PSA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2026-02-27.