Changes in Body Composition With Patients Under Androgen Deprivation Therapy

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04037488
• Other study ID #: SNUH-URO-2018-01
• Status: Not yet recruiting
• Start date: August 2019
• Est. completion date: October 30, 2021

Study information

• Verified date: September 2018
• Source: Seoul National University Hospital
• Contact: Jungyo Suh, MD.
• Phone: +82-10-5190-8098
• Email: crazyslime[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	HanAll BioPharma Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Body composition change-Body mass index (BMI)	{body weight (kg)} / {height (m)^2}	Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
Primary	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
Primary	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	Laboratory changes-PSA	PSA level changes	Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
Secondary	Laboratory changes-Testosterone	Testosterone level changes	Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
Secondary	Oncologic outcomes - recurrence	Any local or distance recurrence	Up to 24 weeks
Secondary	Oncologic outcomes - survival	Any cause of death	Up to 24 weeks