Clinical trial NCT04321187: Influence of Prostate Cancer Radiation on Aging
Official title: Influence of Radiotherapy on the Dynamics of Aging in Prostate Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Aging Disorder
Radiotherapy; Complications
Inflammation
Keywords: telomere length
aging
radiotherapy
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 314
Sex: MALE
Minimum age (years): 70
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functionality - activities of daily living
timeFrame: 2 years
measure: Functionality - instrumental activities of daily living
timeFrame: 2 years
measure: Cognitive disorder
timeFrame: 2 years
measure: Comorbidities
timeFrame: 2 years
measure: Mental disorder
timeFrame: 2 years
measure: Mobility
timeFrame: 2 years
measure: Number of medications taken
timeFrame: 2 years
Secondary outcomes:
measure: Radiation induced toxicity
timeFrame: 10 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz, Dept. of Therapeutic Radiology and Oncology
name: Tanja Langsenlehner
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.