Influence of Prostate Cancer Radiation on Aging

Sponsor
Medical University of Graz (Other)
Overall Status
Recruiting
CT.gov ID
NCT04321187
Collaborator
(none)
334
1
36
9.3

Study Details

Study Description

Brief Summary

Previous studies have reported that cancer survivors develop age-related chronic conditions like frailty, sarcopenia, cardiac dysfunction, and cognitive impairment earlier and/or at a greater burden than similarly aged individuals never diagnosed with cancer or exposed to cancer therapies.

However, the knowledge about aging-associated consequences of cancer treatment and the processes that underlie differential responses to therapy is very limited. In 2018, a think tank established by the National Cancer Institute has defined various research needs to expand the evidence base for aging-related consequences of cancer treatment, such as studies to examine aging-related processes that include regularly performed assessments capturing factors associated with physical function or studies to elucidate pathways that lead to the emergence of aging phenotypes and to understand the relationships between biomarkers of aging and functional outcomes in cancer survivors. In addition, study inclusion of older adults with comorbidities and higher levels of frailty has been proposed to achieve an improved understanding of functional outcomes at any age.

Hypotheses / objectives We hypothesize that prostate cancer radiotherapy accelerates aging-related processes, furthermore, aging-related biomarkers may predict functional outcomes and represent early indicators of aging phenotypes. Primary objectives of the proposed study are the determination of the aging-related consequences of radiotherapy in prostate cancer patients and the evaluation of the relationship between biomarkers of aging and age-related clinical conditions.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Systematic evaluations of functional and cognitive status, comorbidities, health status, mobility, nutritional status, psychological status, and social circumstances as well as measurements of cellular senescence and chronic inflammation will be performed in a cohort of prostate cancer patients at baseline (before radiotherapy), at the end of radiotherapy and at follow-up intervals thereafter. The evaluation of aging-related biomarkers will include determination of markers of cellular senescence and markers of systemic inflammation. The correlation between genetic variants modulating telomere length and the risk of developing age-related phenotypes will also be analyzed.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    334 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Influence of Radiotherapy on the Dynamics of Aging in Prostate Cancer Patients
    Actual Study Start Date :
    Sep 1, 2019
    Anticipated Primary Completion Date :
    Aug 31, 2021
    Anticipated Study Completion Date :
    Aug 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Functionality - activities of daily living [2 years]

      Functional decline measured by Activities of Daily Living examination (range, 0-6; high values indicate high functionality and improved outcome)

    2. Functionality - instrumental activities of daily living [2 years]

      Functional decline measured by the Instrumental Activities of Daily Living examination (range, 0-8; high values indicate high functionality and improved outcome)

    3. Cognitive disorder [2 years]

      Cognitive disorder measured by the Mini-Mental State Examination (range, 0-30; high values indicate normal cognition and improved outcome)

    4. Comorbidities [2 years]

      Comorbidities measured by the Charlson comorbidity index (range, 0-37; high score indicates high rate of comorbidities and worse outcome)

    5. Mental disorder [2 years]

      Mental disorder measured by the Geriatric depression scale (range, 0-30; higher values indicate depression and worse outcome)

    6. Mobility [2 years]

      Mobility measured by the Timed up and go test (≥12 seconds to complete the Timed up and go test indicates mobility impairment and worse outcome)

    7. Number of medications taken [2 years]

      Polypharmacy represents an aging related condition (high number of medication taken indicates worse outcome)

    Secondary Outcome Measures

    1. Radiation induced toxicity [10 years]

      Frequency of acute and late side effects

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    70 Years to 100 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Prostate cancer

    • Candidate to definitive radiation treatment

    • Local or locally advanced disease

    • Aged ≥ 65 years

    • Informed consent

    Exclusion Criteria:
    • Unable to give written informed consent

    • Metastatic disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Graz Graz Austria 8036

    Sponsors and Collaborators

    • Medical University of Graz

    Investigators

    • Principal Investigator: Tanja Langsenlehner, Medical University of Graz, Dept. of Therapeutic Radiology and Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT04321187
    Other Study ID Numbers:
    • 31-437 ex 18/19
    First Posted:
    Mar 25, 2020
    Last Update Posted:
    Apr 14, 2021
    Last Verified:
    Apr 1, 2021
    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
    Keywords provided by Medical University of Graz
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 14, 2021