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Influence of Prostate Cancer Radiation on Aging

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ClinicalTrials.gov Identifier: NCT04321187
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

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
Prostate Cancer Aging Disorder Radiotherapy; Complications Inflammation

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.

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Study Type : Observational
Estimated 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 : September 1, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




Primary Outcome Measures :
  1. Functionality - activities of daily living [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 2 years ]
    Cognitive disorder measured by the Mini-Mental State Examination (range, 0-30; high values indicate normal cognition and improved outcome)

  4. Comorbidities [ Time Frame: 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 [ Time Frame: 2 years ]
    Mental disorder measured by the Geriatric depression scale (range, 0-30; higher values indicate depression and worse outcome)

  6. Mobility [ Time Frame: 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 [ Time Frame: 2 years ]
    Polypharmacy represents an aging related condition (high number of medication taken indicates worse outcome)


Secondary Outcome Measures :
  1. Radiation induced toxicity [ Time Frame: 10 years ]
    Frequency of acute and late side effects


Biospecimen Retention:   Samples With DNA
Ethylenediaminetetraacetic acid blood


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Ages Eligible for Study:   70 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
prostate cancer patients treated at the Department of Therapeutic Radiology and Oncology, Comprehensive Cancer Center, Medical University of Graz. Prostate cancer patients who are candidates for curative radiotherapy will be invited to take part by the local investigators.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321187


Contacts
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Contact: Tanja Langsenlehner, MD 004331638587869 tanja.langsenlehner@medunigraz.at

Locations
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Austria
Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Tanja Langsenlehner, MD    004331638587869    tanja.langsenlehner@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Tanja Langsenlehner Medical University of Graz, Dept. of Therapeutic Radiology and Oncology
Publications:
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT04321187    
Other Study ID Numbers: 31-437 ex 18/19
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: In is not planned to make individual participant data (IPD) available to other researchers.

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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:
telomere length
aging
radiotherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Inflammation
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Pathologic Processes