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

Recruiting

Interventions: Procedure: Biospecimen Collection
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Screening (biospecimen collection)	Questionnaire Administration	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.
Screening (biospecimen collection)	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.
Screening (biospecimen collection)	Quality-of-Life Assessment	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.
Screening (biospecimen collection)	Laboratory Biomarker Analysis	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.

Primary Outcome Measures

Name	Time	Method
Positive predictive values (PPVs) of age-based prostate specific antigen (PSA) thresholds	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 Outcome Measures

Name	Time	Method

Locations (8): City of Hope
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Duarte, California, United States
University of California, San Francisco
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San Francisco, California, United States
Northwestern
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Chicago, Illinois, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States
OHSU Knight Cancer Institute
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Portland, Oregon, United States
University of Pennsylvania/Abramson Cancer Center
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Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
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San Antonio, Texas, United States
Fred Hutch/University of Washington Cancer Consortium
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Seattle, Washington, United States