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NCT Number: NCT04321187

Influence of Prostate Cancer Radiation on Aging

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.

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Key information

Conditions

Prostate Cancer Aging Disorder Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Inflammation Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Radiotherapy; Complications Urogenital Diseases Urogenital Neoplasms

Age range

70 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

Medical University of Graz

Graz, 8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Radiation induced toxicity

    Time frame: 10 years

    Frequency of acute and late side effects

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Influence of Radiotherapy on the Dynamics of Aging in Prostate Cancer Patients

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 25, 2020
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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