Status:
RECRUITING
Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Canary Foundation
Conditions:
Prostate Carcinoma
Eligibility:
MALE
40+ years
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- People with prostates ≥40 years of age
- Documented germline pathogenic variant in known or suspected genes associated with prostate cancer risk.
Exclusion
- 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.
Key Trial Info
Start Date :
May 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2030
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04472338
Start Date
May 21 2020
End Date
August 31 2030
Last Update
November 10 2025
Active Locations (8)
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1
City of Hope
Duarte, California, United States, 91010
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Northwestern
Chicago, Illinois, United States, 60611
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114