Sarcopenia in Older Patient With Prostate Cancer, Prevalence and Incidence After Androgen Deprivation Therapy

NCT ID: NCT04484246

Last Updated: 2020-07-23

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

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-11

Study Completion Date

2020-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Prevalence of sarcopenia in older patient with prostate cancer

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* Protected pateint under guardiaship
* Metastatic prostate cancer
* Patient refusal
* Patient cripled with severe dementia
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emilie Garrido-Pradalié

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

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Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Anne Laure COUDERC

Role: CONTACT

04-91-74-45-30

Facility Contacts

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Anne Laure COUDERC

Role: primary

04-91-74-45-30

References

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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.

Reference Type DERIVED
PMID: 35042460 (View on PubMed)

Other Identifiers

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2019-35

Identifier Type: -

Identifier Source: org_study_id

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