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

Status Not yet recruiting

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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Sarcopenia

• NCT number: NCT04037488
• Study type: Observational
• Source: Seoul National University Hospital
• Contact: Jungyo Suh, MD.
• Phone: +82-10-5190-8098
• Email: crazyslime@gmail.com
• Status: Not yet recruiting
• Start date: August 2019
• Completion date: October 30, 2021