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JOURNAL ONKOLOGIE – STUDIE

Influence of Prostate Cancer Radiation on Aging

Rekrutierend

NCT-Nummer:
NCT04321187

Studienbeginn:
September 2019

Letztes Update:
14.04.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Prostatic Neoplasms, Inflammation

Geschlecht:
Männer

Altersgruppe:
Senioren (66+)

Phase:
-

Sponsor:
Medical University of Graz

Collaborator:
-

Studienleiter

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

Kontakt

Studienlocations
(1 von 1)

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

1. Radiation induced toxicity (Time Frame - 10 years):
Frequency of acute and late side effects

Quelle: ClinicalTrials.gov


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