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

Study Overview
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Brief Summary
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Condition: Prostate cancer Intervention: Biopsy and inherited risk assessment

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Genetic: Genetic Assessment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Men 40-69 years old<br>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 Assessment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate Cancer Diagnosis from Prostate Biopsy Report | The primary outcome measure is prostate cancer diagnosis from the prostate biopsy report. The primary goal is to compare prostate cancer detection rate in patients of three inherited risk groups (high-risk, intermediate-risk, and low-risk). | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The first type of secondary outcome measures is demographic key clinical variables from chart review, including | Age of the patient at recruitment, measured in years Ethnicity, which will be reported as either Hispanic or Latino, or not Hispanic or Latino Race, which will be reported as Black/African American, East Asian, White, or Other Most recent body mass index (BMI), which height and weight will be combined and reported in kg/m^2 Most recent PSA test result prior to prostate biopsy, which will be reported in ng/mL Most recent prostate health index (PHI), which is a combination of three PSA-based blood tests that estimates the probability of having detectable prostate cancer TRUS prostate volume, based on the height, length, and width of the prostate and will be reported in mL | 4 years | 
| The second type of secondary outcome measures is results from multi-parametric Magnetic Resonance Imaging (mpMRI), including | Prostate total volume, measured in mL Overall Prostate Imaging Reporting and Data System (PI-RAD) score, which assesses risk of clinically significant cancer being present or absent Extraprostatic extension, which will be reported as present or absent Seminal vesicle invasion, which will be reported as present or absent Lymph node enlargement, which will be reported as present or absent MRI bone metastasis, which will be reported as present or absent Number of lesions, which will be reported as a numerical value For each lesion, location of lesion, which will be reported as the anatomical region of the prostate where the lesion is present For each lesion, size of lesion, measured in mm For each lesion, PIRAD score of lesion, which assesses risk of clinically significant cancer being present or absent in the lesion | 4 years | 
| The third type of secondary outcome measures is pathological variables from prostate biopsy, including | Type of prostate biopsy that was performed on the patient, which will be reported as either transperineal (TP) or transrectal ultrasound (TRUS) Number of cores positive, which will be reported as a numerical value Number of cores examined, which will be reported as a numerical value Overall Gleason score (primary), which predicts cancer aggressiveness and prognosis Overall Gleason score (secondary), which predicts cancer aggressiveness and prognosis For each core, length of core, measured in cm For each core, length of tumor, measured in mm For each core, % of core positive, which will be reported as a numerical value as a percentage For each core, % Gleason 4 For each core, presence of perineural invasion (PNI), will be reported as Yes or No For each core, presence of cribriform, will be reported as Yes or No | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PSA, Prostate biopsy, prostate cancer, inherited risk assessment