Clinical trial Recruiting at 7 sites Observational Ages 40 and up Men only

Prostate cancer screening for those with genetic risk

Official title: PATROL: Prostate Cancer Screening for People AT Genetic Risk FOr Aggressive Disease

Run by University of Washington · NCT04472338 · Data updated 2026-11-12

This study is testing how regular check-ups and sample collections can help find prostate cancer earlier in people with a genetic risk for aggressive forms of the disease.

Quick facts

Study typeObservational
Ages40 Years and up
SexMen only
Enrollment450 (estimated)
SponsorUniversity of Washington
Academic / other
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations8 sites (Duarte, California and 7 other locations)
StatusRecruiting
StartedMay 21, 2020
Main results expectedAugust 31, 2030
Study endsAugust 31, 2030
Registry record updatedMay 15, 2026
Trial IDNCT04472338 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men aged 40 and older with documented germline pathogenic variants linked to prostate cancer risk.

Probably not a fit

Patients who have already been diagnosed with prostate cancer or have received cancer treatment within the past year may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on early detection of prostate cancer in individuals who have a genetic predisposition to aggressive forms of the disease. Participants will provide blood, urine, and tissue samples every 6-12 months, which will be analyzed to enhance understanding of prostate cancer genetics. The goal is to identify biomarkers that could lead to earlier diagnosis and improved treatment strategies over a period of up to three years.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection of prostate cancer in high-risk individuals, potentially improving treatment outcomes.

How similar studies have gone: Other studies focusing on genetic risk factors for cancer have shown promise, suggesting that this approach may yield valuable insights.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 it's running

  • City of Hope
    Duarte, California, United States
    Recruiting
  • University of California, San Francisco
    San Francisco, California, United States
    Recruiting
  • Northwestern
    Chicago, Illinois, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting
  • OHSU Knight Cancer Institute
    Portland, Oregon, United States
    Recruiting
  • University of Pennsylvania/Abramson Cancer Center
    Philadelphia, Pennsylvania, United States
    Recruiting
Show 2 more locations
  • Fred Hutch/University of Washington Cancer Consortium
    Seattle, Washington, United States
    Recruiting
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas, United States
    Terminated

Study contacts

  • Principal investigator: Heather H. Cheng, MD, PhD — Fred Hutch/University of Washington Cancer Consortium
  • Study coordinator: Study Team Coordinator
  • Email: patrol@uw.edu
  • Phone: 206-210-4040

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.