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Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT04472338.
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Active
Contact: Heather H. Cheng
Phone: 206-606-1406
PRIMARY OBJECTIVE:
I. To determine the positive predictive value of predefined age-directed prostate-specific antigen (PSA) thresholds for biopsy to detect prostate cancer in people with prostates who are germline carriers of known or suspected pathogenic variants in genes associated with prostate cancer risk.
SECONDARY OBJECTIVES:
I. To determine the clinico-pathologic characteristics and natural history of prostate cancer diagnosed in those who are germline carriers of known or suspected pathogenic variants in genes associated with prostate cancer risk.
II. To determine patient-reported outcomes in people with prostates who are germline carriers of known or suspected pathogenic variants in genes associated with prostate cancer risk.
EXPLORATORY OBJECTIVE:
I. To describe performance characteristics (positive predictive value [PPV], negative predictive value [NPV]) of novel biomarkers for predicting the presence of biopsy-proven cancer in those who are at high genetic risk for prostate cancer.
OUTLINE: This is an observational study.
Participants undergo collection of blood, urine, and/or tissue samples every 12 months, when any biopsy occurs, and if relevant, at time of curative therapy and 12 months after completion of curative therapy.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
