Influence of Prostate Cancer Radiation on Aging

Completed

• Conditions: Radiotherapy; Complications; Prostate Cancer; Aging Disorder; Inflammation

• Registration Number: NCT04321187
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 314

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mobility	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	2 years	Polypharmacy represents an aging related condition (high number of medication taken indicates worse outcome)
Functionality - activities of daily living	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	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	2 years	Cognitive disorder measured by the Mini-Mental State Examination (range, 0-30; high values indicate normal cognition and improved outcome)
Comorbidities	2 years	Comorbidities measured by the Charlson comorbidity index (range, 0-37; high score indicates high rate of comorbidities and worse outcome)
Mental disorder	2 years	Mental disorder measured by the Geriatric depression scale (range, 0-30; higher values indicate depression and worse outcome)

Secondary Outcome Measures

Name	Time	Method
Radiation induced toxicity	10 years	Frequency of acute and late side effects

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria