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Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR)

Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03807492
Collaborator
(none)
1,000
Enrollment
1
Location
61.5
Anticipated Duration (Months)
16.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The EMPOWeR study is proposed as a cohort study with longitudinal follow-up to determine rates of genetic mutations among men with or at-risk for prostate cancer to address the various facets of genetic education and counseling for optimized genetic assessment and wellness of men. The results will inform practice guidelines and future studies for maximal impact of genetic evaluation of men for inherited prostate cancer.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR)
    Actual Study Start Date :
    Jan 16, 2019
    Anticipated Primary Completion Date :
    Jan 19, 2024
    Anticipated Study Completion Date :
    Mar 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    EMPOWeR Study

    This is a cohort study, with initial patient assessments and longitudinal follow-up. Participation of subjects will be indefinite, which will be discussed in the informed consent.

    Outcome Measures

    Primary Outcome Measures

    1. Perform genetic testing for men with or at-risk for prostate cancer to determine association of mutations to patient characteristics. [6 months]

      Participants will undergo gene panel testing through a saliva or blood sample. A genetic test summary will be generated to give to participants at disclosure of results. Participants will receive genetic test results in person, by phone or via telehealth. Fisher's exact test will be used to determine association of mutations and variants to patient characteristics.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Men with a personal history of prostate cancer

    • Unaffected males who are at higher risk for prostate cancer (family history of prostate cancer or African American males)

    • Men who previously tested positive for a mutation may be eligible for Specific Aims 2-7

    • Men with a known familial mutation

    • Men who previously participated in the Genetic Evaluation of Men (GEM) study (IRB#14S.546) will be offered participation in EMPOWeR -

    Exclusion Criteria:

    • Age < 18 years

    • Mental or cognitive impairment that interferes with ability to provide informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Thomas Jefferson University Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sidney Kimmel Cancer Center at Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT03807492
    Other Study ID Numbers:
    • 18D.644
    First Posted:
    Jan 17, 2019
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    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 Aug 3, 2022