PATROL: Prostate Cancer Screening for People AT Genetic Risk FOr Aggressive Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Washington
- Enrollment
- 450
- Locations
- 13
- Primary Endpoint
- Positive predictive values (PPVs) of age-based prostate specific antigen (PSA) thresholds
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Screening (biospecimen collection)
Participants undergo collection of blood, urine, and/or tissue samples every 12 months, when any biopsy occurs, and if relevant, at time of curative therapy and 12 months after completion of curative therapy.
Intervention: Biospecimen Collection (Procedure)
Screening (biospecimen collection)
Participants undergo collection of blood, urine, and/or tissue samples every 12 months, when any biopsy occurs, and if relevant, at time of curative therapy and 12 months after completion of curative therapy.
Intervention: Quality-of-Life Assessment (Other)
Screening (biospecimen collection)
Participants undergo collection of blood, urine, and/or tissue samples every 12 months, when any biopsy occurs, and if relevant, at time of curative therapy and 12 months after completion of curative therapy.
Intervention: Laboratory Biomarker Analysis (Other)
Screening (biospecimen collection)
Participants undergo collection of blood, urine, and/or tissue samples every 12 months, when any biopsy occurs, and if relevant, at time of curative therapy and 12 months after completion of curative therapy.
Intervention: Questionnaire Administration (Other)
Outcomes
Primary Outcomes
Positive predictive values (PPVs) of age-based prostate specific antigen (PSA) thresholds
Time Frame: Up to 10 years
To estimate PPVs of age-based PSA thresholds for biopsy referral in this patient population, will first fit a logistic regression model to estimate the odds that biopsy leads to a prostate cancer diagnosis. The regression will have a binary indicator of prostate cancer diagnosis as the response variable, patient age at biopsy (categorized as \< 50, 50-59, or \>= 60 years to correspond to the age-based PSA thresholds) as a fixed effect, and a unique patient identifier as a random effect to account for possibly repeated biopsies. Will then convert the estimated odds that biopsy leads to a prostate cancer diagnosis within each age category into corresponding probabilities of this outcome-i.e., PPV point estimates and associated 95% confidence intervals-using the inverse logit function.
Secondary Outcomes
No secondary outcomes reported