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

University of Washington450 enrolled

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.

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 Type

OBSERVATIONAL

Enrollment

450

Conditions

Prostate Carcinoma

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of blood, urine, and/or tissue samples

Laboratory Biomarker AnalysisOTHER

Correlative studies

Quality-of-Life AssessmentOTHER

Ancillary studies

Eligibility

Sex: MALEMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (8)

City of Hope

Duarte, California, United States

RECRUITING

University of California, San Francisco

San Francisco, California, United States

RECRUITING

Northwestern

Outcomes

Primary Outcomes

Positive predictive values (PPVs) of age-based prostate specific antigen (PSA) thresholds

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.

Time frame: Up to 10 years

Central Contacts

Study Team Coordinator

CONTACT

206-210-4040 patrol@uw.edu

Data from ClinicalTrials.gov

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