Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy
Status
RECRUITING
Phase
Age
40 - 69 Years
Enrollments
1000Conditions
Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Pooja Talaty
- 847-503-4280
- [email protected]
Principal Investigator
- Jianfeng Xu, MD, Dr.PH
Eligibility Criteria
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.
Study Plan
Men 40-69 years old
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).
GENETIC:
Genetic AssessmentDescription:
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 Outcome Measures
Prostate Cancer Diagnosis from Prostate Biopsy Report
Secondary Outcome Measures
The first type of secondary outcome measures is demographic key clinical variables from chart review, including
The second type of secondary outcome measures is results from multi-parametric Magnetic Resonance Imaging (mpMRI), including
The third type of secondary outcome measures is pathological variables from prostate biopsy, including
Timeline
Last Updated
March 27, 2024Start Date
March 25, 2022Today
January 23, 2025Completion Date ( Estimated )
December 13, 2025
Sponsors of this trial
Lead Sponsor
NorthShore University HealthSystemCollaborating Sponsors
Northwestern University, Johns Hopkins University, GoPath Diagnostics
RECRUITING 
21 - 64 Years