Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study
PATROL: Prostate Cancer Screening for People AT Genetic Risk FOr Aggressive Disease
4 other identifiers
observational
450
1 country
8
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2020
CompletedFirst Submitted
Initial submission to the registry
July 10, 2020
CompletedFirst Posted
Study publicly available on registry
July 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2030
November 10, 2025
September 1, 2025
10.3 years
July 10, 2020
November 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Positive predictive values (PPVs) of age-based prostate specific antigen (PSA) thresholds
To estimate PPVs of age-based PSA thresholds for biopsy referral in this patient population, will first fit a logistic regression model to estimate the odds that biopsy leads to a prostate cancer diagnosis. The regression will have a binary indicator of prostate cancer diagnosis as the response variable, patient age at biopsy (categorized as \< 50, 50-59, or \>= 60 years to correspond to the age-based PSA thresholds) as a fixed effect, and a unique patient identifier as a random effect to account for possibly repeated biopsies. Will then convert the estimated odds that biopsy leads to a prostate cancer diagnosis within each age category into corresponding probabilities of this outcome-i.e., PPV point estimates and associated 95% confidence intervals-using the inverse logit function.
Up to 10 years
Study Arms (1)
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.
Interventions
Undergo collection of blood, urine, and/or tissue samples
Ancillary studies
Eligibility Criteria
Germline carriers of pathogenic or likely pathogenic mutations in genes associated with increased risk of prostate cancer
You may qualify if:
- People with prostates ≥40 years of age
- Documented germline pathogenic variant in known or suspected genes associated with prostate cancer risk.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- National Cancer Institute (NCI)collaborator
- Canary Foundationcollaborator
- CureBRCAcollaborator
Study Sites (8)
City of Hope
Duarte, California, 91010, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Northwestern
Chicago, Illinois, 60611, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
Biospecimen
Blood, urine, tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather H. Cheng, MD, PhD
Fred Hutch/University of Washington Cancer Consortium
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2020
First Posted
July 15, 2020
Study Start
May 21, 2020
Primary Completion (Estimated)
August 31, 2030
Study Completion (Estimated)
August 31, 2030
Last Updated
November 10, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share