Observational and Prospective Study on the Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy (GenBx)
Endeavor Health
Summary
Condition: Prostate cancer Intervention: Biopsy and inherited risk assessment
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 associated with prostate cancer (PCa) risk. Furthermore, results from retrospective analyses of two clinical trials (PCPT and REDUCE) and biopsy cohorts revealed Caucasian men with higher GRS are 1) more likely to have positive biopsy and 2) have higher number of positive biopsy cores. These findings suggest inherited risk assessment may have clinical utility in identifying men who have a higher likelihood…
Eligibility
- Age range
- 40–69 years
- Sex
- Male
- Healthy volunteers
- No
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.
Interventions
- GeneticGenetic 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.
Location
- NorthShore University HealthSystemEvanston, Illinois