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NCT Number: NCT04472338

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

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.

Recruiting

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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

City of Hope, Duarte, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biospecimen Collection

Procedure

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

laboratory biomarker analysis

Other

Correlative studies

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

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

    Time frame: Up to 10 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Team Coordinator

CONTACT

[email protected]

206-210-4040

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Canary Foundation
  • CureBRCA
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Jul 15, 2020
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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