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
Principal Investigator
Medical University of Graz, Dept. of Therapeutic Radiology and Oncology
Kontakt
Kontakt:
Phone: 004331638587869
E-Mail: tanja.langsenlehner@medunigraz.at» Kontaktdaten anzeigen
Studienlocations
(1 von 1)
8036 Graz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Tanja Langsenlehner, MD
Phone: 004331638587869
E-Mail: tanja.langsenlehner@medunigraz.at» Ansprechpartner anzeigen
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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