HoSAGE: sarcopenia in older patient with intermediate / high-risk prostate cancer, prevalence and incidence after androgen deprivation therapy: study protocol for a cohort trial

Abstract

Background 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. Methods 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. Discussion 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. Trial registration 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).

Resistance Exercise Training, a Simple Intervention to Preserve Muscle Mass and Strength in Prostate Cancer Patients on Androgen Deprivation Therapy

“…However, besides aging, it is nowadays recognized that many other causes can contribute to sarcopenia, like malnutrition, inactivity, diseases, and iatrogenic factors like drugs (e.g., ADT; Cruz-Jentoft & Sayer, 2019). Therefore, differentiating the relation between ADT-related muscle loss and sarcopenia-for example, to explore the impact of ADT on the occurrence and exacerbating of sarcopenia-receives more and more attention (Couderc et al, 2020(Couderc et al, , 2022Owen et al, 2019).…”

The association of testosterone with sarcopenia and frailty in chronic liver disease

“…40,41 Indeed, several studies have shown that patients with prostate cancer on ADT have higher risk for sarcopenia. [42][43][44] Two independent studies of prostate cancer patients initiating ADT, showed that lean body mass was significantly decreased by 2.7%-3.8% from baseline to 1 year later. 45,46 The co-existence of chronic liver disorder further exacerbates the muscle catabolism via the dysregulated liver-muscle-adipose tissue triangle that leads to increased release of interleukin (IL)-6, tumour necrosis factor-a (TNF-α) and IGF-1 that promotes muscle catabolism.…”

“…ADT treatment leads to hypogonadism which facilitates significant decrease of skeletal lean muscle mass along with increase of total body fat mass 40,41 . Indeed, several studies have shown that patients with prostate cancer on ADT have higher risk for sarcopenia 42–44 . Two independent studies of prostate cancer patients initiating ADT, showed that lean body mass was significantly decreased by 2.7%–3.8% from baseline to 1 year later 45,46 .…”

The importance of body composition in patients with prostate cancer receiving radiotherapy

“…Prospective studies examining ADT's effect on body composition in men with intermediate-and high-risk prostate cancer are under way and will hopefully shed more light on these possibilities. 16 The authors also evaluated for an association with other body composition metrics and association with outcomes, including adipose density, psoas muscle density, and bone mineral density, in addition to PMA. In the analysis, body composition measurements were analyzed as both continuous and categorical variables.…”

“…In patients with ADT‐induced sarcopenia, either resistance training or a shorter treatment course could be considered depending on patient motivation and available resources. Prospective studies examining ADT’s effect on body composition in men with intermediate‐ and high‐risk prostate cancer are under way and will hopefully shed more light on these possibilities 16 …”