Influence of Prostate Cancer Radiation on Aging

NCT04321187 | Completed

• 1 other identifier: 31-437 ex 18/19
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Aging Disorder; Radiotherapy; Complications; Inflammation

Keywords

telomere length; aging; radiotherapy

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• Cognitive disorder

  Cognitive disorder measured by the Mini-Mental State Examination (range, 0-30; high values indicate normal cognition and improved outcome)

  2 years

• Comorbidities

  Comorbidities measured by the Charlson comorbidity index (range, 0-37; high score indicates high rate of comorbidities and worse outcome)

  2 years

• Mental disorder

  Mental disorder measured by the Geriatric depression scale (range, 0-30; higher values indicate depression and worse outcome)

  2 years

• 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

• Number of medications taken

  Polypharmacy represents an aging related condition (high number of medication taken indicates worse outcome)

  2 years

Secondary Outcomes (1)

• Radiation induced toxicity

  10 years

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

prostate cancer patients treated at the Department of Therapeutic Radiology and Oncology, Comprehensive Cancer Center, Medical University of Graz. Prostate cancer patients who are candidates for curative radiotherapy will be invited to take part by the local investigators.

You may qualify if:

• Prostate cancer
• Candidate to definitive radiation treatment
• Local or locally advanced disease
• Aged ≥ 65 years
• Informed consent

You may not qualify if:

• Unable to give written informed consent
• Metastatic disease

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

Related Publications (2)

• 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.

  PMID: 30082901 BACKGROUND

• 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.

  PMID: 31321426 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Ethylenediaminetetraacetic acid blood

MeSH Terms

Conditions

Prostatic Neoplasms; Inflammation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tanja Langsenlehner

  Medical University of Graz, Dept. of Therapeutic Radiology and Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 25, 2020
• Study Start: September 1, 2019
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)