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

About the Study

The PATROL (Prostate Cancer Screening for People AT Genetic Risk FOr Aggressive Disease) study is for people at risk for prostate cancer because they carry one or more genes that are known or suspected to increase prostate cancer risk: BRCA2, HOXB13, ATM, BRCA1, MLH1, MSH2, MSH6, PALB2, PMS2, CHEK2, RAD51D, or TP53.

This is a good study for people who wish to be proactive about their care and contribute to studying new ways of monitoring for prostate cancer risk, including studying new markers for finding prostate cancer early. Participation involves study visits approximately once a year with physical exam, blood tests (including PSA) and urine test. Biopsies and imaging may be advised based on exam and blood test results. There are also patient questionnaires. Contact [email protected] or go to http://sites.uw.edu/patrolstudy for more information.

What the Study Involves

The PATROL study is an early-detection screening study. Study procedures include annual clinic visit, PSA (Prostate Specific Antigen) blood test, and prostate imaging as deemed necessary by your doctor. A prostate biopsy may be recommended based on age and PSA if you are:

• under 50, with a PSA over 1.0 ng/mL
• between 50 and 59 with a PSA over 1.5 ng/mL
• over 60 with a PSA over 2.0 ng/mL

At each annual PATROL visit, participants will be asked to fill out a survey, and blood and urine samples will be collected for the PATROL biorepository. The annual visits and collections will be conducted for 10 years after enrollment. For people who are diagnosed with prostate cancer during the study, the medical care plan will be determined by the patient’s urologist and medical team.

Study Locations

California

Duarte
City of Hope
Contact Samantha Rutledge 626-218-7269

San Francisco
University of California, San Francisco

Illinios

Chicago
Northwestern University
Contact Nikki Hubbard 312-694-1188

Massachusetts

Boston
Massachusetts General Hospital
Contact  Aileen Feng 617-726-8850 

Oregon

Portland
OHSU Knight Cancer Institute
Contact Sarah Clampitt 503-418-8150

Pennsylvania

Philadelphia
University of Pennsylvania/Abramson Cancer Center
Contact Caitlin Orr 215-615-3004

Washington

Seattle
Fred Hutchinson Cancer Center/University of Washington
Contact Chenee Holcomb 206-598-0850

Lead Researchers/Study PIs and Affiliation

Heather H. Cheng, MD, PhD University of Washington / Fred Hutchinson Cancer Center;
Daniel W. Lin, MD; University of Washington
[email protected]

The study is open to people with prostates, who are at least 40 years old AND:

• Have an inherited mutation known in the following genes: BRCA2, HOXB13, ATM, BRCA1, MLH1, MSH2, MSH6, PALB2, PMS2, CHEK2, RAD51D, or TP53.
• Do not already have a diagnosis of prostate cancer.
• Are able to provide written informed consent.

People with the following are not eligible:

• have another cancer treated within the past 12 months (e.g. surgery, radiation, chemotherapy, immunotherapy) for all cancer types except non melanoma skin cancer.
• prior participation or plan to participate in a clinical trial intended to prevent cancer for people with genetic mutations linked to hereditary cancer risk.
• Unable or unwilling to complete clinical care and study procedures as indicated by the study requirements.
• Prior or concurrent participation in an interventional clinical trial aimed at preventing cancer for people with germline variants associated with increased prostate cancer risk.