NCT04472338 · University of Washington
Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study
What this study is about
This study investigates ways to detect prostate cancer earlier in people at genetic risk for disease that forms, grows, or spreads quickly (aggressive).
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo collection of blood, urine, and/or tissue samples
OTHER
Laboratory Biomarker Analysis
Correlative studies
OTHER
Quality-of-Life Assessment
Ancillary studies
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
Positive predictive values (PPVs) of age-based prostate specific antigen (PSA) thresholds
Time frame: Up to 10 years
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Duarte, California
- San Francisco, California
- Chicago, Illinois
- Boston, Massachusetts
- Portland, Oregon
- Philadelphia, Pennsylvania
- San Antonio, Texas
- Seattle, Washington
Collaborators
National Cancer Institute (NCI), Canary Foundation, CureBRCA
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 15, 2026 · Source of record for eligibility and locations