Sarcopenia is defined by a loss of muscle strength associated to a decrease in skeletal muscle mass. Ageing greatly contributes to sarcopenia as may many other factors such as cancer or androgen deprivation therapies (ADT). This cohort study aims to evaluate (1) the prevalence of muscle disorders and sarcopenia in older patients before initiation of intermediate to high risk prostate cancer treatment with ADT and radiotherapy, and (2) the occurrence and/or aggravation of muscle disorders and sarcopenia at the end of cancer treatment.
This cohort study is monocentric and prospective. The primary objectives are to determine the risk factor of sarcopenia prevalence and to study the relationship between ADT and sarcopenia incidence, in patients 70 years and older with histologically proven localized or locally advanced prostate cancer, addressed to a geriatrician (G8 score ≤14) for comprehensive geriatric assessment (CGA) in Marseille University Hospital. Secondary objectives encompass, measurement of sarcopenia clinical criteria along prostate oncological treatment; evaluation of the quality of life of patients with sarcopenia; evaluation of the impact of socio-behavioral and anthropological factors on sarcopenia evolution and incidence; finally the evaluation of the impact of ADT exposure on sarcopenia. Sarcopenia prevalence was estimated to be between 20 and 30%, therefore the study will enroll 200 patients.
The current guidelines for older patients with prostate cancer recommend a pelvic radiotherapy treatment associated to variable duration (6 to 36 months) of ADT. However ADT impacts muscle mass and could exacerbate the risks of sarcopenia. Our study intends to assess the specific effect of ADT on sarcopenia incidence and/or worsening as well as to estimate sarcopenia prevalence in this population. The results of this cohort trial will lead to a better understanding of sarcopenia prevalence and incidence necessary to further elaborate a prevention plan.
The protocol was registered to the French drug and device regulation agency under the number 2019-A02319-48, before beginning the study (11/12/2019). The ClinicalTrials.gov identifier is NCT04484246, registration on the ClinicalTrials.gov ( https://clinicaltrials.gov/ct2/show/NCT04484246 ).
BMC cancer. 2022 Jan 18*** epublish ***
Anne-Laure Couderc, Patrick Villani, Julie Berbis, Emilie Nouguerède, Dominique Rey, Dominique Rossi, Éric Lechevallier, Delphine Badinand, Cyrille Bastide, Gilles Karsenty, Romain Boissier, Kahena Amichi, Xavier Muracciole
Internal Medicine, Geriatrics and Therapeutic Unit, Sainte-Marguerite Hospital, AP-HM, 270 Boulevard Sainte Marguerite, 13009, Marseille, France. ., Internal Medicine, Geriatrics and Therapeutic Unit, Sainte-Marguerite Hospital, AP-HM, 270 Boulevard Sainte Marguerite, 13009, Marseille, France., Epidemiology and Health Economics Unit, La Timone Hospital, AP-HM, 13385, Marseille, cedex 05, France., Urological Surgery Unit, Nord Hospital, AP-HM, Chemin des Bourrely, 13915, Marseille, cedex 20, France., Urological Surgery and Renal Transplantation Unit, Conception Hospital, AP-HM, 147 Boulevard Baille, 13005, Marseille, France., Radiotherapy Unit, Timone Hospital, AP-HM, 264 Rue Saint Pierre, 13385, Marseille, cedex 05, France., Direction de la Recherche Clinique et de l'Innovation (DRCI), Assistance Publique des Hôpitaux de Marseille (AP-HM), 80 Rue Brochier, 13354, Marseille, Cedex 05, France.