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Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study

NCT04472338 · University of Washington
In plain English

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Official title
PATROL: Prostate Cancer Screening for People AT Genetic Risk FOr Aggressive Disease
About this study
OUTLINE: Participants undergo collection of blood, urine, and/or tissue samples every 6-12 months, when any biopsy occurs, and if relevant, at time of curative therapy and 3-9 months after completion of curative therapy for up to 3 years.
Eligibility 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.
Study design
Enrollment target: 450 participants
Age groups: adult, older_adult
Timeline
Starts: 2020-05-21
Estimated completion: 2030-08-31
Last updated: 2025-11-10
Interventions
Procedure: Biospecimen CollectionOther: Laboratory Biomarker AnalysisOther: Quality-of-Life AssessmentOther: Questionnaire Administration
Primary outcomes
  • Positive predictive values (PPVs) of age-based prostate specific antigen (PSA) thresholds (Up to 10 years)
Sponsor
University of Washington · other
With: National Cancer Institute (NCI), Canary Foundation, CureBRCA
Contacts & investigators
ContactStudy Team Coordinator · contact · patrol@uw.edu · 206-210-4040
InvestigatorHeather H. Cheng, MD, PhD · principal_investigator, Fred Hutch/University of Washington Cancer Consortium
All locations (8)
City of HopeRecruiting
Duarte, California, United States
University of California, San FranciscoRecruiting
San Francisco, California, United States
NorthwesternRecruiting
Chicago, Illinois, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
OHSU Knight Cancer InstituteRecruiting
Portland, Oregon, United States
University of Pennsylvania/Abramson Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at San AntonioTerminated
San Antonio, Texas, United States
Fred Hutch/University of Washington Cancer ConsortiumRecruiting
Seattle, Washington, United States