NCT05295407

Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Endeavor Health · Academic / Other
• Sex: Male
• Age: 40 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
GENETIC	Genetic 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.

Timeline

• Start date: 2021-12-13
• Primary completion: 2026-12-13
• Completion: 2027-12-13
• First posted: 2022-03-25
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States