Clinical trial NCT04484246: Sarcopenia in Older Patient With Prostate Cancer, Prevalence and Incidence After Androgen Deprivation Therapy
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 200
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients 70 years or older with localized or locally advanced prostate cancer.

Brief 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. 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


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of sarcopenia in older patient with prostate cancer
timeFrame: 36 months
Secondary outcomes:
measure: Evaluation of sarcopenia severity
timeFrame: 36 months
measure: Skeletal Muscular Index
timeFrame: 36 months
measure: Evaluation of sarcopenia severity
timeFrame: 36 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Emilie Garrido-Pradalié
role: STUDY_DIRECTOR
References:
citation: 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.