Recruiting

Prostate Cancer Screening

Sponsor:

University of Washington

Code:

NCT04472338

Conditions

Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Accepted

Interventions

Biospecimen Collection

Laboratory Biomarker Analysis

Quality-of-Life Assessment

Questionnaire Administration

Study Details

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.

Conditions

Prostate Carcinoma

Study ID

NCT04472338

Start date

May 21, 2020

Status verified date

May, 2026

Completion date

Aug 31, 2030

Anticipated

Primary completion date

Aug 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Accepted

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 Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biospecimen Collection

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

Laboratory Biomarker Analysis

Correlative studies

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Positive predictive values (PPVs) of age-based prostate specific antigen (PSA) thresholds [ Time Frame: Up to 10 years ]

Central Contacts and Locations

Central contacts

Study Team Coordinator

206-210-4040patrol@uw.edu

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Principal Investigator:

Joanne Jeter, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Ada Sanchez

ada.sanchez@ucsf.edu

Principal Investigator:

Matthew Cooperberg, MD, MPH

Northwestern

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Sophia Kallas

Sophia.kallas@northwestern.edu

Principal Investigator:

Hiten Patel, MD, MPH

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Keyan Salari, MD, PhD

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Alexandra Sokolova, MD

503-418-8150cedartrials@ohsu.edu

Principal Investigator:

Alexandra Sokolova, MD

University of Pennsylvania/Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Kara Maxwell, MD, PhD

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

Principal Investigator:

Kara Maxwell, MD, PhD

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Study Team Coordinator

206-210-4040patrol@uw.edu

Principal Investigator:

Heather H. Cheng, MD, PhD

More Information

Sponsor

University of Washington

Last update posted

May 15, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Washington on 2026-05-15.