Prostate CancerHoSAGENCT04484246
Sarcopenia in Older Patient With Prostate Cancer, Prevalence and Incidence After Androgen Deprivation Therapy
An observational study of Prostate Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Prostate cancer is the most common cancer among men 50 years and older and mainly affets patients 75 years old. Androgen deprivation therapy is indicatated in intermediates and high risks form of prostate cancer, in association with radiotherapy for 6 monts to 3 years. It is also indicated after surgery. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prevalence of sarcopenia in older patient with prostate cancer
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2019to 28 Sep 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: patients 70 years or older with localized or locally advanced prostate cancer.
Who may be able to join
- Patients aged 70 years and older
- Proven localized or locally advanced prostate cancer
- Treated by radiotherapy associated to ADT
- CGA needed (screened by G8 Score ≤14)
Who cannot join
- Protected pateint under guardiaship
- Metastatic prostate cancer
- Patient refusal
- Patient cripled with severe dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Incidence and Prevalence of Sarcopenia in Patients 70 Year and Older With Localized and Locally Advanced Porstate Cancer, Treated by Radiotherapy and Androgen Deprivation Therapy. a Monocentric Cohort Trial
Prostate cancer is the most common cancer among men 50 years and older and mainly affets patients 75 years old.
Androgen deprivation therapy is indicatated in intermediates and high risks form of prostate cancer, in association with radiotherapy for 6 monts to 3 years. It is also indicated after surgery. Current therapies induce inhibition of sexual hormones as androgens among which testosterone. These therapies present side effects which have to be acknowledeged during the elaboration therapeutic startegies in older patients: hypogonadism induced by androgen deprivation therapy (ADT) causes loss of bone mineral density, diminution of lean body mass and increase of fat body mass.
Sarcopenia is defined by a loss of muscle strength associated to a decrease in skeletal muscle mass. In addition to aging, many factors may contribute to sarcopenia as cancer and/or ADT. This cohort study aims to evaluate risk factors associated to sarcopenia prevalence and the relationship between ADT and sarcopenia incidence, in patients 70 years or older with localized or locally advanced prostate cancer
- Conditions
- Prostate Cancer
- Being tested
- Prevalence of sarcopenia in older patient with prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevalence of sarcopenia in older patient with prostate cancerOther
All patients are screened for sarcopenia with the SAR-F questionnaire test score ≥4/10 suspected of sarcopenia will undergo a dual-X-ray exam to dertemine their skeletal muscle mass and the prevalence of sarcopenia before oncological treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sarcopenia in older patient with prostate cancer
All patients are screened for sarcopenia with the SAR-F questionnaire test
Measured: 36 months
Secondary outcomes (3)
Evaluation of sarcopenia severity
The severity of the sarcopenia will be measured by the evaluation of the physical performances
Measured: 36 months
Skeletal Muscular Index
Sarcopenia prevalence measuring Skeletal Muscular Index (SMI= Appendicular skeletal muscle mass/height²) using dual-energy X-ray absorptiometry (DXA)
Measured: 36 months
Evaluation of sarcopenia severity
The severity of the sarcopenia will be measured by the evaluation of the muscle strength using gait speed test
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start11 Dec 2019
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Assistance Publique Hopitaux De MarseilleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Garrido-Pradalié, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484246
- Sponsor's protocol ID
- 2019-35
- Acronym
- HoSAGE
- Status last verified
- Feb 2026
- First submitted
- 6 Jul 2020
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Couderc AL, Villani P, Berbis J, Nouguerede E, Rey D, Rossi D, Lechevallier E, Badinand D, Bastide C, Karsenty G, Boissier R, Amichi K, Muracciole X. HoSAGE: sarcopenia in older patient with intermediate / high-risk prostate cancer, prevalence and incidence after androgen deprivation therapy: study protocol for a cohort trial. BMC Cancer. 2022 Jan 18;22(1):78. doi: 10.1186/s12885-021-09105-8.
PubMed 35042460
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Incidence and Prevalence of Sarcopenia in Patients 70 Year and Older With Localized and Locally Advanced Porstate Cancer, Treated by Radiotherapy and Androgen Deprivation Therapy. a Monocentric Cohort Trial
- ClinicalTrials.gov ID
- NCT04484246
- Acronym / sponsor ID
- HoSAGE / 2019-35
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 23 Jul 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.
Prostate cancer is the most common cancer among men 50 years and older and mainly affets patients 75 years old.
Androgen deprivation therapy is indicatated in intermediates and high risks form of prostate cancer, in association with radiotherapy for 6 monts to 3 years. It is also indicated after surgery. Current therapies induce inhibition of sexual hormones as androgens among which testosterone. These therapies present side effects which have to be acknowledeged during the elaboration therapeutic startegies in older patients: hypogonadism induced by androgen deprivation therapy (ADT) causes loss of bone mineral density, diminution of lean body mass and increase of fat body mass.
Sarcopenia is defined by a loss of muscle strength associated to a decrease in skeletal muscle mass. In addition to aging, many factors may contribute to sarcopenia as cancer and/or ADT. This cohort study aims to evaluate risk factors associated to sarcopenia prevalence and the relationship between ADT and sarcopenia incidence, in patients 70 years or older with localized or locally advanced prostate cancer
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patients 70 years or older with localized or locally advanced prostate cancer.
Key inclusion criteria (4 listed)
- Patients aged 70 years and older
- Proven localized or locally advanced prostate cancer
- Treated by radiotherapy associated to ADT
- CGA needed (screened by G8 Score ≤14)
Key exclusion criteria (4 listed)
- Protected pateint under guardiaship
- Metastatic prostate cancer
- Patient refusal
- Patient cripled with severe dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevalence of sarcopenia in older patient with prostate cancerAll patients are screened for sarcopenia with the SAR-F questionnaire test score ≥4/10 suspected of sarcopenia will undergo a dual-X-ray exam to dertemine their skeletal muscle mass and the prevalence of sarcopenia before oncological treatment. | Other | – |
Primary outcome
Prevalence of sarcopenia in older patient with prostate cancer
Time frame: 36 months
All patients are screened for sarcopenia with the SAR-F questionnaire test
3 secondary outcomes
Evaluation of sarcopenia severity
Time frame: 36 months
Skeletal Muscular Index
Time frame: 36 months
Evaluation of sarcopenia severity
Time frame: 36 months
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 4 Feb 2026.
- Derived from this study: PubMed 35042460Couderc AL, Villani P, Berbis J, Nouguerede E, Rey D, Rossi D, Lechevallier E, Badinand D, Bastide C, Karsenty G, Boissier R, Amichi K, Muracciole X. HoSAGE: sarcopenia in older patient with intermediate / high-risk prostate cancer, prevalence and incidence after androgen deprivation therapy: study protocol for a cohort trial. BMC Cancer. 2022 Jan 18;22(1):78. doi: 10.1186/s12885-021-09105-8.
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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.
Emilie Garrido-Pradalié study director
Assistance Publique Hôpitaux de Marseille
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, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 4 inclusion and 4 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 4 Feb 2026. 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 France. 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?
Prevalence of sarcopenia in older patient with prostate cancer (time frame: 36 months). 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 NCT04484246, which also lists 1 linked publication.
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 4 Feb 2026.