Assessing inherited risk for predicting prostate cancer from biopsies
Observational and Prospective Study on the Performance of Inherited Risk Assessment for Predicting Prostate Cancer From Prostate Biopsy (GenBx)
This study is testing if looking at inherited genetic risks can help doctors better predict prostate cancer outcomes from biopsies in patients of different races.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 40 Years to 69 Years |
| Sex | Male |
| Sponsor | Endeavor Health Academic / other |
| Locations | 1 site (Evanston, Illinois) |
| Trial ID | NCT05295407 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of inherited genetic risk assessments in predicting prostate cancer outcomes from biopsies. It focuses on identifying rare pathogenic mutations and genetic risk scores associated with prostate cancer risk among multi-racial patients. By analyzing data from patients undergoing prostate biopsy, the study seeks to confirm the clinical utility of these genetic assessments in improving diagnostic accuracy. The findings could influence clinical guidelines regarding prostate cancer screening and biopsy decision-making.
Who should consider this trial
Good fit: Ideal candidates are men aged 40 to 69 years from diverse ethnic backgrounds undergoing prostate biopsy with PSA levels between 2.5-10 ng/mL.
Not a fit: Patients with a previous diagnosis of prostate cancer or those outside the specified ethnicities and PSA range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of prostate cancer diagnoses and improve patient outcomes through tailored screening strategies.
How similar studies have performed: Previous studies have shown promising results in using genetic assessments for prostate cancer risk prediction, suggesting this approach has potential clinical utility.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Evanston, Illinois
- NorthShore University HealthSystem — Evanston, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Jianfeng Xu, MD, Dr.PH — Endeavor Health
- Study coordinator: Annie Ashworth
- Email: aashworth@northshore.org
- Phone: 2243647502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.