Prostate CancerNCT04321187
Influence of Prostate Cancer Radiation on Aging
An observational study of Prostate Cancer and Aging Disorder, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 70 to 100 years, men only
- Conditions the study is for
- Prostate Cancer, Aging Disorder, Radiotherapy; Complications
- How many people
- 314 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2019to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 100 years
- Men only
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Prostate cancer
- Candidate to definitive radiation treatment
- Local or locally advanced disease
- Aged ≥ 65 years
- Informed consent
Who cannot join
- Unable to give written informed consent
- Metastatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Radiotherapy on the Dynamics of Aging in Prostate Cancer Patients
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.
Read the 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.
- Keywords
- telomere length, aging, radiotherapy
- Medical subject headings
- Prostatic Neoplasms, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 2 years
Cognitive disorder
Cognitive disorder measured by the Mini-Mental State Examination (range, 0-30; high values indicate normal cognition and improved outcome)
Measured: 2 years
Comorbidities
Comorbidities measured by the Charlson comorbidity index (range, 0-37; high score indicates high rate of comorbidities and worse outcome)
Measured: 2 years
Mental disorder
Mental disorder measured by the Geriatric depression scale (range, 0-30; higher values indicate depression and worse outcome)
Measured: 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)
Measured: 2 years
Number of medications taken
Polypharmacy represents an aging related condition (high number of medication taken indicates worse outcome)
Measured: 2 years
Secondary outcomes (1)
Radiation induced toxicity
Frequency of acute and late side effects
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Sep 2019
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanja Langsenlehner, Principal investigator, Medical University of Graz, Dept. of Therapeutic Radiology and Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321187
- Sponsor's protocol ID
- 31-437 ex 18/19
- Status last verified
- May 2023
- First submitted
- 23 Mar 2020
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In is not planned to make individual participant data (IPD) available to other researchers.
Publications
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.
PubMed 30082901Guida 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.
PubMed 31321426
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Radiotherapy on the Dynamics of Aging in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT04321187
- Acronym / sponsor ID
- 31-437 ex 18/19
- Keywords
- telomere length, aging, radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- Prostate cancer
- Candidate to definitive radiation treatment
- Local or locally advanced disease
- Aged ≥ 65 years
- Informed consent
Key exclusion criteria (2 listed)
- Unable to give written informed consent
- Metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
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)
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)
Mental disorder
Time frame: 2 years
Mental disorder measured by the Geriatric depression scale (range, 0-30; higher values indicate depression and worse outcome)
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)
Number of medications taken
Time frame: 2 years
Polypharmacy represents an aging related condition (high number of medication taken indicates worse outcome)
1 secondary outcome
Radiation induced toxicity
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Background: PubMed 30082901Renner 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.
- Background: PubMed 31321426Guida 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.
- Individual participant dataSharing planned: No. In is not planned to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanja Langsenlehner principal investigator
Medical University of Graz, Dept. of Therapeutic Radiology and Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Aging Disorder, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functionality - activities of daily living (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04321187, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.