Changes in Body Composition With Patients Under Androgen Deprivation Therapy

• Conditions: Prostate Cancer; Sarcopenia
• Interventions: Diagnostic Test: Inbody 320

• Registration Number: NCT04037488
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2019-07-26
• Last Update Submitted: 2019-07-26
• Study First Posted: 2019-07-30
• Last Update Posted: 2019-07-30
• Study Start: 2019-08
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 56

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort: ADT patients	Inbody 320	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of