Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 37 of 1543 for:    Androgens

Changes in Body Composition With Patients Under Androgen Deprivation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04037488
Recruitment Status : Not yet recruiting
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
HanAll BioPharma Co., Ltd.
Information provided by (Responsible Party):
Seoul National University Hospital

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).

Condition or disease Intervention/treatment
Sarcopenia Prostate Cancer 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Body Compositions Change in Patients With Prostate Cancer Treated With Androgen Deprivation Therapy
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: Body composition change




Primary Outcome Measures :
  1. Body composition change-Skeletal muscle index (SMI) [ Time Frame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months ]
    Lean body mas (kg) / body weight (kg) x 100 (%)

  2. Body composition change-Body mass index (BMI) [ Time Frame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months ]
    {body weight (kg)} / {height (m)^2}

  3. Body composition change-Relative skeletal muscle index (RASM) [ Time Frame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months ]
    Sum of skeletal muscle mass in limbs (kg) / {height (m)^2}

  4. Body composition change - fat body mass (FBM) [ Time Frame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months ]
    fat body mass (FBM) calculated by Inbody 320


Secondary Outcome Measures :
  1. Laboratory changes-PSA [ Time Frame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months ]
    PSA level changes

  2. Laboratory changes-Testosterone [ Time Frame: Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months ]
    Testosterone level changes

  3. Oncologic outcomes - recurrence [ Time Frame: Up to 24 weeks ]
    Any local or distance recurrence

  4. Oncologic outcomes - survival [ Time Frame: Up to 24 weeks ]
    Any cause of death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037488


Contacts
Layout table for location contacts
Contact: Jungyo Suh, MD. +82-10-5190-8098 crazyslime@gmail.com
Contact: Chang Wook Jeong, MD. PHD. drboss@gmail.com

Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
HanAll BioPharma Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Chang Wook Jeong, MD. PHD. Seoul National University Hospital

Layout table for additonal information
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04037488     History of Changes
Other Study ID Numbers: SNUH-URO-2018-01
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: September 2018

Layout table for additional information
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
Keywords provided by Seoul National University Hospital:
Androgen deprivation therapy
Prostate cancer
Body composition
Lean body mass
Additional relevant MeSH terms:
Layout table for MeSH terms
Androgens
Prostatic Neoplasms
Sarcopenia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs