Spots Global Cancer Trial Database for Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy

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Trial Identification

Brief Title: Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy

Official Title: Observational and Prospective Study on the Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy (GenBx)

Study ID: NCT05295407

Conditions

Prostate Cancer

Interventions

Genetic Assessment

Study Description

Brief 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.