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

February 24, 2026 updated by: Jianfeng Xu, Endeavor Health

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

Condition: Prostate cancer Intervention: Biopsy and inherited risk assessment

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60626
        • Recruiting
        • Northshore University Healthsystem
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jianfeng Xu, MD, DrPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Men with moderately-elevated PSA (2.5-10 ng/mL) undergoing prostate biopsy for detecting prostate cancer at NorthShore University HealthSystem, Johns Hopkins Hospital, and Northwestern University.

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prostate Cancer Diagnosis from Prostate Biopsy Report
Time Frame: 4 years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The first type of secondary outcome measures is demographic key clinical variables from chart review, including
Time Frame: 4 years
  • 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
Time Frame: 4 years
  • 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
Time Frame: 4 years
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Endeavor Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins University
Northwestern University
GoPath Diagnostics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jianfeng Xu, MD, Dr.PH, Endeavor Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EH21-338 (Other Identifier: NorthShoreUH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The plan is to release de-identified genomic and clinical data for approved researchers to replicate study or use for other discoveries.

IPD Sharing Time Frame

Data will become available after the study (after analysis) indefinitely

IPD Sharing Access Criteria

With approval, researchers will be able to access published, de-identified data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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