Influence of Prostate Cancer Radiation on Aging

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04321187
• Other study ID #: 31-437 ex 18/19
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 70 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging Disorder
• Inflammation
• Prostate Cancer
• Prostatic Neoplasms
• Radiotherapy; Complications

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Cognitive disorder	Cognitive disorder measured by the Mini-Mental State Examination (range, 0-30; high values indicate normal cognition and improved outcome)	2 years
Primary	Comorbidities	Comorbidities measured by the Charlson comorbidity index (range, 0-37; high score indicates high rate of comorbidities and worse outcome)	2 years
Primary	Mental disorder	Mental disorder measured by the Geriatric depression scale (range, 0-30; higher values indicate depression and worse outcome)	2 years
Primary	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
Primary	Number of medications taken	Polypharmacy represents an aging related condition (high number of medication taken indicates worse outcome)	2 years
Secondary	Radiation induced toxicity	Frequency of acute and late side effects	10 years