Clinical trial NCT04037488: Changes in Body Composition With Patients Under Androgen Deprivation Therapy
Official title: Body Compositions Change in Patients With Prostate Cancer Treated With Androgen Deprivation Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcopenia
Prostate Cancer
Keywords: Androgen deprivation therapy
Prostate cancer
Body composition
Lean body mass
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: HanAll BioPharma Co., Ltd.
First posted: 2019-07-30
Enrollment: 56
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body composition change-Skeletal muscle index (SMI)
timeFrame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
measure: Body composition change-Body mass index (BMI)
timeFrame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
measure: Body composition change-Relative skeletal muscle index (RASM)
timeFrame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
measure: Body composition change - fat body mass (FBM)
timeFrame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
Secondary outcomes:
measure: Laboratory changes-PSA
timeFrame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
measure: Laboratory changes-Testosterone
timeFrame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months
measure: Oncologic outcomes - recurrence
timeFrame: Up to 24 weeks
measure: Oncologic outcomes - survival
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chang Wook Jeong, MD. PHD.
role: PRINCIPAL_INVESTIGATOR
References: