Changes in Body Composition With Patients Under Androgen Deprivation Therapy

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

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

Study Overview

• Status: Unknown
• Conditions: Sarcopenia; Prostate Cancer
• Intervention / Treatment: Diagnostic test: Inbody 320

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 Type: Observational
• Enrollment (Anticipated): 56

Contacts and Locations

• Study Contact: Name: Jungyo Suh, MD.; Phone Number: +82-10-5190-8098; Email: crazyslime@gmail.com
• Study Contact Backup: Name: Chang Wook Jeong, MD. PHD.; Email: drboss@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Patient with long-term (more than 2 year) androgen deprivation therapy for treatment of prostate cancer, without any other malignancy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Cohort: ADT patients; 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; 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; Other Names: Body composition change

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: HanAll BioPharma Co., Ltd.
• Investigators: Principal Investigator: Chang Wook Jeong, MD. PHD., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2019
• Primary Completion (ANTICIPATED): October 30, 2021
• Study Completion (ANTICIPATED): October 30, 2021

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (ACTUAL): July 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Prostate cancer; Body composition; Androgen deprivation therapy; Lean body mass
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neurologic Manifestations; Genital Neoplasms, Male; Prostatic Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Prostatic Neoplasms; Sarcopenia
• Other Study ID Numbers: SNUH-URO-2018-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No