Key Eligibility:
– People with prostates who are of at least 40 years of age who:
- Have an inherited pathogenic mutation known or suspected to increase risk of prostate cancer in the following genes: BRCA2, HOXB13, ATM, BRCA1, MSH2, MSH6, PMS2, CHEK2, or TP53
- Do not already have a diagnosis of prostate cancer
- Are able to provide written informed consent.
Exclusion Criteria:
- Prior diagnosis of prostate cancer
- Unable to provide written informed consent
- Have another cancer treated with curative intent within the past 12 months (e.g. surgery, radiation, chemotherapy, immunotherapy) for all cancer types except non melanoma skin cancer
- Prior or current participation in an interventional clinical trial intended to prevent cancer for people with germline pathogenic mutations in known or suspected genes associated with cancer risk.
- Unable or unwilling to complete clinical care and study procedures as indicated by the study protocol
Study Procedures:
- PATROL is designed to be conducted alongside the standard of care protocol for prostate cancer
- Study procedures include annual physical exam, PSA (Prostate Specific Antigen) blood test, and prostate imaging as deemed necessary per attending clinician
- A prostate biopsy will be advised based on age and PSA and is always recommended at the discretion of the clinician. If you are under 50, that is PSA over 1.0 ng/mL. If you are between 50 and 59, PSA over 1.5 ng/mL, and over 60, PSA over 2.0 ng/mL.
- Participants will have annual PATROL visits where blood and urine samples will be collected for the PATROL biorepository
- Participants will be recommended to have prostate MRI at baseline and within 1 year prior of every prostate biopsy
- The annual visits and collections will be conducted for 10 years after enrollment per PATROL protocol
- Upon diagnosis of prostate cancer, clinical care will be determined through discussion with the patient’s urologist and medical team (e.g. chemotherapy and radiation, surgery, active surveillance)
Aims:
- To determine the efficacy of using predefined PSA thresholds and prostate-specific imaging (e.g. PSMA-PET scan, MRI Prostate, CT Abdomen and Pelvis) to guide the timing of biopsy that will result in a positive diagnosis
- To evaluate clinical and research biomarkers relevant to prostate cancer
- To understand the impact of screening on multiple aspects of patient health