Prostate Cancer Clinical Trial
Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy
Condition: Prostate cancer Intervention: Biopsy and inherited risk assessment
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.
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
Previous diagnosis of prostate cancer.
Ethnicity outside the inclusion criterion (including mixed ethnicity).
Any prior PSA test result outside the range of inclusion criterion.
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