RecruitingObservational

PATROL: Prostate Cancer Screening for People AT Genetic Risk FOr Aggressive Disease

NCT ID: NCT04472338Sponsor: University of WashingtonLast updated: 2026-05-15

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.

Arms & interventions

ProcedureBiospecimen Collection
Undergo collection of blood, urine, and/or tissue samples
OtherLaboratory Biomarker Analysis
Correlative studies
OtherQuality-of-Life Assessment
Ancillary studies
OtherQuestionnaire Administration
Ancillary studies

Outcome measures

Primary

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

Eligibility criteria

Sex: MaleAge: 40 Years and olderHealthy 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.

Study locations (8)

City of Hope

Duarte, California, 91010

Recruiting

Joanne Jeter, MD · Principal Investigator

University of California, San Francisco

San Francisco, California, 94143

Recruiting

Ada Sanchez · Contact

ada.sanchez@ucsf.edu

Matthew Cooperberg, MD, MPH · Principal Investigator

Northwestern

Chicago, Illinois, 60611

Recruiting

Sophia Kallas · Contact

Sophia.kallas@northwestern.edu

Edward Schaeffer, MD, PhD · Sub Investigator

Hiten Patel, MD, MPH · Principal Investigator

Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting

Keyan Salari, MD, PhD · Principal Investigator

OHSU Knight Cancer Institute

Portland, Oregon, 97239

Recruiting

Alexandra Sokolova, MD · Contact

503-418-8150 cedartrials@ohsu.edu

Alexandra Sokolova, MD · Principal Investigator

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104

Recruiting

Kara Maxwell, MD, PhD · Contact

215-615-3004 PATROL@pennmedicine.upenn.edu

Kara Maxwell, MD, PhD · Principal Investigator

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

Terminated

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109

Recruiting

Study Team Coordinator · Contact

206-210-4040 patrol@uw.edu

Heather H. Cheng, MD, PhD · Principal Investigator