Observational and Prospective Study on the Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy (GenBx)
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 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 of positive results from diagnostic prostate biopsy. The objective of this observational trial is to confirm the clinical utility of both RPMs and GRS in a prospective study of multi-racial patients. Results from this trial will provide a critical piece of evidence for guideline committees to consider the adoption of inherited risk assessment in decision making for prostate biopsy.
Arms & 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.
Outcome measures
Primary
Prostate Cancer Diagnosis from Prostate Biopsy Report
The primary outcome measure is prostate cancer diagnosis from the prostate biopsy report. The primary goal is to compare prostate cancer detection rate in patients of three inherited risk groups (high-risk, intermediate-risk, and low-risk).
Time frame: 4 years
Secondary
The first type of secondary outcome measures is demographic key clinical variables from chart review, including
Time frame: 4 years
The second type of secondary outcome measures is results from multi-parametric Magnetic Resonance Imaging (mpMRI), including
Time frame: 4 years
The third type of secondary outcome measures is pathological variables from prostate biopsy, including
Time frame: 4 years
Eligibility criteria
Study locations (1)
NorthShore University HealthSystem
Evanston, Illinois, 60626
References
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