Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study
NCT ID: NCT04472338
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2020-05-21
2030-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Screening (biospecimen collection)
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.
Biospecimen Collection
Undergo collection of blood, urine, and/or tissue samples
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Biospecimen Collection
Undergo collection of blood, urine, and/or tissue samples
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented germline pathogenic variant in known or suspected genes associated with prostate cancer risk.
Exclusion Criteria
* 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.
40 Years
MALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Canary Foundation
OTHER
CureBRCA
UNKNOWN
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Heather H. Cheng, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Ada Sanchez
Role: primary
Sophia Kallas
Role: primary
Alexandra Sokolova, MD
Role: primary
Kara Maxwell, MD, PhD
Role: primary
Study Team Coordinator
Role: primary
Other Identifiers
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NCI-2020-04602
Identifier Type: REGISTRY
Identifier Source: secondary_id
8760
Identifier Type: OTHER
Identifier Source: secondary_id
RG1004195
Identifier Type: OTHER
Identifier Source: secondary_id
RG1004195
Identifier Type: -
Identifier Source: org_study_id