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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Carcinoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Biospecimen Collection

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.

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Study Team Coordinator; Phone Number: 206-210-4040; Email: patrol@uw.edu

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope
      • Principal Investigator: Joanne Jeter, MD
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Principal Investigator: Matthew Cooperberg, MD, MPH
      • Contact: Ada Sanchez; Email: ada.sanchez@ucsf.edu
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern
      • Sub-Investigator: Edward Schaeffer, MD, PhD
      • Principal Investigator: Hiten Patel, MD, MPH
      • Contact: Sophia Kallas; Email: Sophia.kallas@northwestern.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Keyan Salari, MD, PhD
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • OHSU Knight Cancer Institute
      • Principal Investigator: Alexandra Sokolova, MD
      • Contact: Alexandra Sokolova, MD; Phone Number: 503-418-8150; Email: cedartrials@ohsu.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania/Abramson Cancer Center
      • Contact: Kara Maxwell, MD, PhD; Phone Number: 215-615-3004; Email: PATROL@pennmedicine.upenn.edu
      • Principal Investigator: Kara Maxwell, MD, PhD
  • Texas
    • San Antonio, Texas, United States, 78229
      • Terminated
      • University of Texas Health Science Center at San Antonio
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Principal Investigator: Heather H. Cheng, MD, PhD
      • Contact: Study Team Coordinator; Phone Number: 206-210-4040; Email: patrol@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Germline carriers of pathogenic or likely pathogenic mutations in genes associated with increased risk of prostate cancer

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo collection of blood, urine, and/or tissue samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 10 years

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI); Canary Foundation; CureBRCA
• Investigators: Principal Investigator: Heather H. Cheng, MD, PhD, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2020
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2030

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: RG1004195 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); P50CA097186 (U.S. NIH Grant/Contract); NCI-2020-04602 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 8760 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No