Changes in Body Composition With Patients Under Androgen Deprivation Therapy

Study Overview
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Brief Summary
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This study aimed to evaluate the correlation of change in body composition and oncological outcomes of prostate cancer patients under androgen deprivation therapy(ADT).

Detailed Description
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Sarcopenia, decrease lean body mass (LBM) is the well-known parameter which negatively related to physical activity, morbidity and patients survival. Aging and decreased blood androgen level are well known risk factors of sarcopenia in male population. Androgen deprivation therapy (ADT) is commonly performed in advanced or recurred prostate cancer patient and lead to accelerating decreasing blood androgen level. The previous studies defined the sarcopenia after ADT by calculated the (muscle component area) / (total body area) on computed tomography (CT) scan. However, CT scan is not recommended for routine follow up examination of ADT patients thus this measurement of sarcopenia has limitation on clinical usage. This study using Inbody 320 for measure body composition. Inbody 320 based on multi-frequency Bioelectrical Impedance Analysis(BIA) method that calculated specific body component by differences in impedance indexes of fat, muscle and extracellular body fluid. Inbody measurement show precision accuracy and safety on body composition measurement, thus it frequently used in studies of obesity, nutrition and sports fields. We calculating the total skeletal muscle mass (SMM), skeletal muscle index(SMI), relative skeletal muscle mass index (RASM), fat body mass (FBM), body mass index (BMI), body fat percentage, body water content, and edema value by Inbody 320 in the patients who treated by ADT in prostate cancer patients. Enrolled patients check the body composition parameters at the baseline (before ADT) and after ADT 3,6,12,18,24 months. We prospectively measuring the 2 years changes of body composition and sarcopenia after ADT treatment. Patients characteristics (Age, underlying disease), Prostate cancer status (PSA level, Gleason grade group, initial treatment), ADT methods characters (timing, type) and oncological outcome (Recurrence, Metastasis, Castration resistance) were measuring in the cohort population. Post hoc analysis were performed in the timing (initial, salvage or adjuvant) or type (LHRH agonist, Antiandrogen or surgical castration) of ADT for development of sarcopenia. Sub-arm analysis were performed for assessing that effect of presence of sarcopenia on oncological outcome and functional outcomes after ADT.

Official Title
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Body Compositions Change in Patients With Prostate Cancer Treated With Androgen Deprivation Therapy

Conditions
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Sarcopenia, Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: Inbody 320


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 20 year-old Patient with ECOG-PS 0 to 2 Prostate cancer patients Considered Androgen deprivation therapy with any cause Patient agreed with informed consent of this study Exclusion Criteria: History of previous ADT Planned intermittent treatment or short term ADT (less than 2 year) Contraindication of ADT Severe cognitive impairment, who cannot eligible for survey Secondary malignancy Patient cannot perform InBody test because of physical or underlying disease.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort: ADT patients<br>All enrolled patient data entered in single group cohort. All patient who started androgen deprivation therapy for prostate cancer can included this cohort by following inclusion and exclusion criteria. We do not planned any intervention on this cohort. We measuring changes of body composition by Inbody 320 in the planned follow-up period. We planned sub-group analysis for timing of intervention (Intervention 1) , ADT type(Intervention 2), LHRH agonist type(Intervention 3), patients age(Intervention 4), initial PSA level (Intervention 5) and Gleason Grade Group (Intervention 6). | Diagnostic Test: Inbody 320<br>* Total Skeletal muscle mass (SMM), Skeletal muscle index (SMI), Relative Skeletal muscle mass index (RASM), Fat body mass (FBM), Body mass index (BMI), Body fat percentage, Body water content, Edema Value were calculated by Inbody 320<br>* Other names: Body composition change;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition change-Skeletal muscle index (SMI) | Lean body mas (kg) / body weight (kg) x 100 (%) | Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months | 
| Body composition change-Body mass index (BMI) | {body weight (kg)} / {height (m)^2} | Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months | 
| Body composition change-Relative skeletal muscle index (RASM) | Sum of skeletal muscle mass in limbs (kg) / {height (m)^2} | Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months | 
| Body composition change - fat body mass (FBM) | fat body mass (FBM) calculated by Inbody 320 | Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory changes-PSA | PSA level changes | Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months | 
| Laboratory changes-Testosterone | Testosterone level changes | Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months | 
| Oncologic outcomes - recurrence | Any local or distance recurrence | Up to 24 weeks | 
| Oncologic outcomes - survival | Any cause of death | Up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Androgen deprivation therapy, Prostate cancer, Body composition, Lean body mass