Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study
Status
RECRUITING
Phase
Age
≥ 40 Years
Enrollments
450Conditions
Prostate CarcinomaSummary
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.
Detailed Description
OUTLINE:
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.
Locations
3 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Alexandra Sokolova, MD
- 503-418-8150
- [email protected]
Principal Investigator
- Heather H. Cheng, MD, PhD
Status
- RECRUITING
Contact Person
- Kara Maxwell, MD, PhD
- 215-615-3004
- [email protected]
Principal Investigator
- Heather H. Cheng, MD, PhD
Status
- RECRUITING
Contact Person
- Study Team Coordinator
- 206-210-4040
- [email protected]
Principal Investigator
- Heather H. Cheng, MD, PhD
Eligibility 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.
Study Plan
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.
PROCEDURE:
Biospecimen CollectionDescription:
Undergo collection of blood, urine, and/or tissue samplesOTHER:
Laboratory Biomarker AnalysisDescription:
Correlative studiesOTHER:
Quality-of-Life AssessmentDescription:
Ancillary studiesOTHER:
Questionnaire AdministrationDescription:
Ancillary studies
Outcome Measures
Primary Outcome Measures
Positive predictive values (PPVs) of age-based prostate specific antigen (PSA) thresholds
Timeline
Last Updated
October 8, 2024Start Date
July 15, 2020Today
May 11, 2025Completion Date ( Estimated )
August 31, 2030
Sponsors of this trial
Lead Sponsor
University of WashingtonCollaborating Sponsors
National Cancer Institute (NCI), Canary Foundation, CureBRCA
RECRUITING 
≥ 18 Years