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
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|
|Study Type :||Observational|
|Estimated Enrollment :||334 participants|
|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|
- 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)
- 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)
- 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)
- 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)
- Mental disorder [ Time Frame: 2 years ]Mental disorder measured by the Geriatric depression scale (range, 0-30; higher values indicate depression and worse outcome)
- 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)
- Number of medications taken [ Time Frame: 2 years ]Polypharmacy represents an aging related condition (high number of medication taken indicates worse outcome)
- Radiation induced toxicity [ Time Frame: 10 years ]Frequency of acute and late side effects
Biospecimen Retention: Samples With DNA
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
|Contact: Tanja Langsenlehner, MDfirstname.lastname@example.org|
|Medical University of Graz||Recruiting|
|Graz, Austria, 8036|
|Contact: Tanja Langsenlehner, MD 004331638587869 email@example.com|
|Principal Investigator:||Tanja Langsenlehner||Medical University of Graz, Dept. of Therapeutic Radiology and Oncology|