NCT04484246

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2023

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3.8 years

First QC Date

July 6, 2020

Last Update Submit

February 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of sarcopenia in older patient with prostate cancer

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

    36 months

Secondary Outcomes (3)

  • Evaluation of sarcopenia severity

    36 months

  • Skeletal Muscular Index

    36 months

  • Evaluation of sarcopenia severity

    36 months

Interventions

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.

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

patients 70 years or older with localized or locally advanced prostate cancer.

You may qualify if:

  • 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)

You may not qualify if:

  • Protected pateint under guardiaship
  • Metastatic prostate cancer
  • Patient refusal
  • Patient cripled with severe dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Emilie Garrido-Pradalié

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 23, 2020

Study Start

December 11, 2019

Primary Completion

September 28, 2023

Study Completion

September 28, 2023

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations