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Changes in Body Composition With Patients Under Androgen Deprivation Therapy

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04037488
Enrollment
56
Registered
2019-07-30
Start date
2019-08-31
Completion date
2021-10-30
Last updated
2019-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Sarcopenia

Keywords

Androgen deprivation therapy, Prostate cancer, Body composition, Lean body mass

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.

Interventions

DIAGNOSTIC_TESTInbody 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

Sponsors

HanAll BioPharma Co., Ltd.
CollaboratorINDUSTRY
Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Body composition change - fat body mass (FBM)Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 monthsfat body mass (FBM) calculated by Inbody 320
Body composition change-Skeletal muscle index (SMI)Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 monthsLean body mas (kg) / body weight (kg) x 100 (%)
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 monthsSum of skeletal muscle mass in limbs (kg) / {height (m)\^2}

Secondary

MeasureTime frameDescription
Laboratory changes-PSABaseline (preADT) and Post ADT 3, 6, 12, 18, 24 monthsPSA level changes
Laboratory changes-TestosteroneBaseline (preADT) and Post ADT 3, 6, 12, 18, 24 monthsTestosterone level changes
Oncologic outcomes - recurrenceUp to 24 weeksAny local or distance recurrence
Oncologic outcomes - survivalUp to 24 weeksAny cause of death

Countries

South Korea

Contacts

Primary ContactJungyo Suh, MD.
crazyslime@gmail.com+82-10-5190-8098
Backup ContactChang Wook Jeong, MD. PHD.
drboss@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026