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

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04484246
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 12.7
• Patients Per Site Per Month: 15.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Other: Prevalence of sarcopenia in older patient with prostate cancer

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Dec 11, 2019
• Actual Primary Completion Date: Jul 6, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Outcome Measures

Primary Outcome Measures

1. Prevalence of sarcopenia in older patient with prostate cancer [36 months]

   All patients are screened for sarcopenia with the SAR-F questionnaire test

Secondary Outcome Measures

1. Evaluation of sarcopenia severity [36 months]

   The severity of the sarcopenia will be measured by the evaluation of the physical performances

2. Skeletal Muscular Index [36 months]

   Sarcopenia prevalence measuring Skeletal Muscular Index (SMI= Appendicular skeletal muscle mass/height²) using dual-energy X-ray absorptiometry (DXA)

3. Evaluation of sarcopenia severity [36 months]

   The severity of the sarcopenia will be measured by the evaluation of the muscle strength using gait speed test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hôpitaux de Marseille	Marseille		France	13354

Sponsors and Collaborators

• Assistance Publique Hopitaux De Marseille

Investigators

• Study Director: Emilie Garrido-Pradalié, Assistance Publique Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT04484246
• Other Study ID Numbers: 2019-35
• First Posted: Jul 23, 2020
• Last Update Posted: Jul 23, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms; Sarcopenia

Study Results

No Results Posted as of Jul 23, 2020