Prostate cancer screening for those with genetic risk
PATROL: Prostate Cancer Screening for People AT Genetic Risk FOr Aggressive Disease
This study is testing how regular check-ups and sample collections can help find prostate cancer earlier in people with a genetic risk for aggressive forms of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | University of Washington Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 8 sites (Duarte, California and 7 other locations) |
| Trial ID | NCT04472338 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on early detection of prostate cancer in individuals who have a genetic predisposition to aggressive forms of the disease. Participants will provide blood, urine, and tissue samples every 6-12 months, which will be analyzed to enhance understanding of prostate cancer genetics. The goal is to identify biomarkers that could lead to earlier diagnosis and improved treatment strategies over a period of up to three years.
Who should consider this trial
Good fit: Ideal candidates are men aged 40 and older with documented germline pathogenic variants linked to prostate cancer risk.
Not a fit: Patients who have already been diagnosed with prostate cancer or have received cancer treatment within the past year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of prostate cancer in high-risk individuals, potentially improving treatment outcomes.
How similar studies have performed: Other studies focusing on genetic risk factors for cancer have shown promise, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * People with prostates ≥40 years of age * Documented germline pathogenic variant in known or suspected genes associated with prostate cancer risk. Exclusion Criteria: * Prior diagnosis of prostate cancer * Medical contraindication to any of the study procedures (e.g., prostate biopsy) * For all cancer types except non-melanoma skin cancer, any cancer treatment with curative intent within the past 12 months (e.g., surgery, radiation, chemotherapy, immunotherapy) * Prior or concurrent participation in an interventional clinical trial aimed at preventing cancer for people with germline variants associated with increased prostate cancer risk * Unable to provide written informed consent * Unable or unwilling to complete clinical care and study procedures as indicated by the study protocol.
Where this trial is running
Duarte, California and 7 other locations
- City of Hope — Duarte, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Northwestern — Chicago, Illinois, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- OHSU Knight Cancer Institute — Portland, Oregon, United States (Recruiting)
- University of Pennsylvania/Abramson Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (Terminated)
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Heather H. Cheng, MD, PhD — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Study Team Coordinator
- Email: patrol@uw.edu
- Phone: 206-210-4040
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.