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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04321187
Other study ID # 31-437 ex 18/19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date March 31, 2023

Study information

Verified date May 2023
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 314
Est. completion date March 31, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender Male
Age group 70 Years to 100 Years
Eligibility 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

Study Design


Locations

Country Name City State
Austria Medical University of Graz Graz

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (2)

Guida JL, Ahles TA, Belsky D, Campisi J, Cohen HJ, DeGregori J, Fuldner R, Ferrucci L, Gallicchio L, Gavrilov L, Gavrilova N, Green PA, Jhappan C, Kohanski R, Krull K, Mandelblatt J, Ness KK, O'Mara A, Price N, Schrack J, Studenski S, Theou O, Tracy RP, Hurria A. Measuring Aging and Identifying Aging Phenotypes in Cancer Survivors. J Natl Cancer Inst. 2019 Dec 1;111(12):1245-1254. doi: 10.1093/jnci/djz136. — View Citation

Renner W, Krenn-Pilko S, Gruber HJ, Herrmann M, Langsenlehner T. Relative telomere length and prostate cancer mortality. Prostate Cancer Prostatic Dis. 2018 Nov;21(4):579-583. doi: 10.1038/s41391-018-0068-3. Epub 2018 Aug 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Functionality - activities of daily living Functional decline measured by Activities of Daily Living examination (range, 0-6; high values indicate high functionality and improved outcome) 2 years
Primary Functionality - instrumental activities of daily living Functional decline measured by the Instrumental Activities of Daily Living examination (range, 0-8; high values indicate high functionality and improved outcome) 2 years
Primary Cognitive disorder Cognitive disorder measured by the Mini-Mental State Examination (range, 0-30; high values indicate normal cognition and improved outcome) 2 years
Primary Comorbidities Comorbidities measured by the Charlson comorbidity index (range, 0-37; high score indicates high rate of comorbidities and worse outcome) 2 years
Primary Mental disorder Mental disorder measured by the Geriatric depression scale (range, 0-30; higher values indicate depression and worse outcome) 2 years
Primary Mobility 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) 2 years
Primary Number of medications taken Polypharmacy represents an aging related condition (high number of medication taken indicates worse outcome) 2 years
Secondary Radiation induced toxicity Frequency of acute and late side effects 10 years
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