Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy (GenBx)

NorthShore University HealthSystem

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Genetic: Genetic Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT05295407

EH21-338 (Other Identifier)

Details and patient eligibility

About

Condition: Prostate cancer Intervention: Biopsy and inherited risk assessment

Full 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.

Enrollment: 1,000 estimated patients

Sex: Male

Ages: 40 to 69 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Men 40-69 years old

Description:

Men with moderately-elevated PSA (2.5-10 ng/mL) undergoing prostate biopsy for detecting prostate cancer at NorthShore University HealthSystem, Northwestern University, or Johns Hopkins Hospital. The trial will not alter any clinical practice for diagnostic biopsy that includes state-of-the-art procedures (transperineal fusion biopsy, multiparametric MRI, and novel biomarkers).

Treatment:

Genetic: Genetic Assessment