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Prostate Screening for Men With Inherited Risk of Developing Aggressive Prostate Cancer, PATROL Study

Sponsor
University of Washington (Other)
Overall Status
Recruiting
CT.gov ID
NCT04472338
Collaborator
National Cancer Institute (NCI) (NIH)
450
Enrollment
1
Location
39.3
Anticipated Duration (Months)
11.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study investigates ways to detect prostate cancer earlier in men who are at increased genetic risk of developing prostate cancer 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection
  • Other: Laboratory Biomarker Analysis
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration

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.

After completion of study, participants are followed up annually.

Study Design

Study Type:
Observational
Anticipated Enrollment :
450 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
PATROL: Prostate Screening for Men With Inherited Risk of Developing Aggressive Prostate Cancer
Actual Study Start Date :
May 21, 2020
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Screening (biospecimen collection)

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.

Procedure: Biospecimen Collection
Undergo collection of blood, urine, and/or tissue samples

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Clinical variables as predictors of prostate cancer diagnosis [Up to 3 years]

      Descriptive statistics, parametric and non-parametric statistical tests will be used to summarize the clinical variables as predictors of prostate cancer diagnosis during the early detection study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Provided documented informed consent according to local Institutional Review Board for acquisition of clinical and research specimens

    • Documented germline pathogenic or likely pathogenic mutation/variant in a known or suspected cancer predisposition gene: BRCA2, BRCA1, ATM, CHEK2, PALB2, MLH1, MSH2, MSH6, PMS2, TP53, HOXB13, additional genes included at investigators discretion

    • No prior diagnosis of invasive prostate adenocarcinoma

    • No active malignancy within 1 year of entry. Active malignancy is defined as those malignancies requiring treatment with anti-cancer therapy or in the event of indolent malignancies, having measurable disease. Exceptions to this exclusion include: myelodysplasia, treated non-melanoma skin cancer, completely resected stage 0 or 1 melanoma, carcinoma in situ

    • Life expectancy at least 5 years

    • Participant is accessible and compliant for follow-up

    • Willing and able to undergo screening procedures, including digital rectal exam (DRE) and prostate biopsy, if indicated by study criteria

    Exclusion Criteria:

    • Unwillingness, inability or medical contraindication to undergo screening procedures, including prostate biopsy, if indicated by study criteria

    • Life expectancy < 5 years

    • Prior diagnosis of prostate cancer

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutch/University of Washington Cancer Consortium Seattle Washington United States 98109

    Sponsors and Collaborators

    • University of Washington
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Heather H. Cheng, Fred Hutch/University of Washington Cancer Consortium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Washington
    ClinicalTrials.gov Identifier:
    NCT04472338
    Other Study ID Numbers:
    • RG1004195
    • NCI-2020-04602
    • 8760
    • RG1004195
    • P50CA097186
    First Posted:
    Jul 15, 2020
    Last Update Posted:
    May 16, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of May 16, 2022