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 — GENETIC
    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.

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 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).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NorthShore University HealthSystemEvanstonIllinois60626
Pooja Talaty
847-503-4280
Malgorzata Antoniak
847-570-2112
Jianfeng Xu, MD, DrPH (PRINCIPAL_INVESTIGATOR)

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