Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study

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

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.

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.

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.