PATROL Study: Prostate Cancer Screening for People AT Genetic Risk FOr Aggressive Disease
https://www.facingourrisk.org/research-clinical-trials/study/291/patrol-study-prostate-cancer-screening-for-people-at-genetic-risk-for-aggressive-disease
Clinicaltrials.gov identifier:
NCT04472338 (https://clinicaltrials.gov/show/NCT04472338)
Prevention
Screening study for people with a mutation linked to prostate cancer risk
Study Contact Information:
Contact [email protected] or by phone at 206-210-4040.
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
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
Texas
San Antonio
University of Texas Health Science Center at San Antonio
Contact Molly Doris 210-567-1172
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]
This Study is Open To:
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.
This Study is Not Open To:
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.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.