RecruitingNCT04472338

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

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


Sponsor

University of Washington

Enrollment

450 participants

Start Date

May 21, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 40 Years

Inclusion Criteria2

  • People with prostates ≥40 years of age
  • Documented germline pathogenic variant in known or suspected genes associated with prostate cancer risk.

Exclusion Criteria6

  • 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.

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


Locations(8)

City of Hope

Duarte, California, United States

University of California, San Francisco

San Francisco, California, United States

Northwestern

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

OHSU Knight Cancer Institute

Portland, Oregon, United States

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT04472338


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