Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy
Part of paid clinical trials in Evanston, Illinois.
- Sponsor
- Endeavor Health
- Study ID
- NCT05295407
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- MALE
- Age
- 40 Years - 69 Years
- Healthy Volunteers
- Not accepted
Interventions
- Genetic Assessment — GENETICThe 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.
Study Details
Condition: Prostate cancer Intervention: Biopsy and inherited risk assessment
Key Dates
- Start date
- Dec 13, 2021
- Status verified
- Feb 2026
- Primary completion
- Dec 13, 2026
- Completion
- Dec 13, 2027
Study Design
- Enrollment
- 1,000 participants (estimated)
Arms
- Arm: Men 40-69 years oldMen 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).
Primary Outcome Measure
Prostate Cancer Diagnosis from Prostate Biopsy Report [ Time Frame: 4 years ]
Central Contacts
- Annie Ashworth2243647502
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| NorthShore University HealthSystem | Evanston | Illinois | 60626 | Jianfeng Xu, MD, DrPH (PRINCIPAL_INVESTIGATOR) |
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