Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study
Recruiting · NCT04472338 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Washington
View the official record on ClinicalTrials.gov →Interventions studied
Biospecimen CollectionLaboratory Biomarker AnalysisQuality-of-Life AssessmentQuestionnaire Administration
What this trial is about
This study investigates ways to detect prostate cancer earlier in people at genetic risk for disease that forms, grows, or spreads quickly (aggressive). Studying samples of blood, urine, and/or tissue in the laboratory may help doctors further understand the genetics of prostate cancer and help identify ways to detect cancer earlier, thereby improving treatment and methods of early detection in the future.
Who can take part
Age range
40 Years and older
Sex
Male
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
8 locations listed across 7 US states.
- City of Hope - Duarte, California, United States
- University of California, San Francisco - San Francisco, California, United States
- Northwestern - Chicago, Illinois, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- OHSU Knight Cancer Institute - Portland, Oregon, United States
- University of Pennsylvania/Abramson Cancer Center - Philadelphia, Pennsylvania, United States
- University of Texas Health Science Center at San Antonio - San Antonio, Texas, United States
- Fred Hutch/University of Washington Cancer Consortium - Seattle, Washington, United States