NCT04037488

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

July 30, 2019

Status Verified

September 1, 2018

Enrollment Period

2.2 years

First QC Date

November 29, 2018

Last Update Submit

July 26, 2019

Conditions

SarcopeniaProstate Cancer

Keywords

Androgen deprivation therapyProstate cancerBody compositionLean body mass

Outcome Measures

Primary Outcomes (4)

  • 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

  • Body composition change-Body mass index (BMI)

    {body weight (kg)} / {height (m)\^2}

    Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months

  • 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

  • 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 Outcomes (4)

  • Laboratory changes-PSA

    Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months

  • Laboratory changes-Testosterone

    Baseline (preADT) and Post ADT 3, 6, 12, 18, 24 months

  • Oncologic outcomes - recurrence

    Up to 24 weeks

  • Oncologic outcomes - survival

    Up to 24 weeks

Study Arms (1)

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

Interventions

Inbody 320DIAGNOSTIC_TEST

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

Also known as: Body composition change
Cohort: ADT patients

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with long-term (more than 2 year) androgen deprivation therapy for treatment of prostate cancer, without any other malignancy.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

SarcopeniaProstatic Neoplasms

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Chang Wook Jeong, MD. PHD.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jungyo Suh, MD.

CONTACT

+82-10-5190-8098crazyslime@gmail.com

Chang Wook Jeong, MD. PHD.

CONTACT

drboss@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2018

First Posted

July 30, 2019

Study Start

August 1, 2019

Primary Completion

October 30, 2021

Study Completion

October 30, 2021

Last Updated

July 30, 2019

Record last verified: 2018-09

Locations

KR(1)