NCT05295407 · Endeavor Health
Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy
(GenBx)
What this study is about
Condition: Prostate cancer Intervention: Biopsy and inherited risk assessment
View original scientific description
Condition: Prostate cancer Intervention: Biopsy and inherited risk assessment
Interventions
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.
Primary outcome measures
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Evanston, Illinois
Collaborators
Northwestern University, Johns Hopkins University, GoPath Diagnostics
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations