Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: Prostate Carcinoma. Basic parameters: from 40 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PATROL: Prostate Cancer Screening for People AT Genetic Risk FOr Aggressive Disease
Overview
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.
Interventions
- Procedure Biospecimen Collection
Undergo collection of blood, urine, and/or tissue samples - Other Laboratory Biomarker Analysis
Correlative studies - Other Quality-of-Life Assessment
Ancillary studies - Other Questionnaire Administration
Ancillary studies
Primary outcome measures
- Positive predictive values (PPVs) of age-based prostate specific antigen (PSA) thresholds [Time frame: Up to 10 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 8 centers
- City of Hope — Duarte
- University of California, San Francisco — San Francisco
- Northwestern — Chicago
- Massachusetts General Hospital — Boston
- OHSU Knight Cancer Institute — Portland
- University of Pennsylvania/Abramson Cancer Center — Philadelphia
- University of Texas Health Science Center at San Antonio — San Antonio
- Fred Hutch/University of Washington Cancer Consortium — Seattle
Identifiers
NCT: NCT04472338 · RG1004195 · NCI-2020-04602 · 8760 · RG1004195 · P50CA097186