Influence of Prostate Cancer Radiation on Aging

NCT ID: NCT04321187

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

314 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer Aging Disorder Radiotherapy; Complications Inflammation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tanja Langsenlehner

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type BACKGROUND
PMID: 30082901 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31321426 (View on PubMed)

Other Identifiers

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31-437 ex 18/19

Identifier Type: -

Identifier Source: org_study_id

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