Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer

Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer Treated With Androgen Deprivation Therapy.

The overall goal of this pilot project is to test the hypothesis that a decline in muscle strength precedes the decline in bone strength in men undergoing androgen deprivation therapy (ADT) for prostate cancer. The investigators will measure changes in serum biomarkers involved in muscle-bone crosstalk, anatomic changes in muscle and bone structure and strength that could ultimately contribute to fractures. The findings from this research will inform design of interventions to reduce falls and hip fractures in patients undergoing ADT as well as application to broader populations of at risk patients.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer

Detailed Description

Twenty-five men from urology clinic with prostate cancer will be recruited and enrolled prior to initiating ADT and studied at three time points. Baseline (before first does of ADT), and at approximately weeks 6 and 24 while receiving ADT for prostate cancer. Study measures will be the same during each of three data acquisition time points and include ascertainment of venous blood to determine serum biochemical markers of muscle and bone metabolic activity, MRI and CT imaging studies to assess muscle strength, volume, composition, bone volume, density and strength, and validated tests of muscle strength. Subjects will serve as their own controls.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390-8889
      • UT Southwestern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men with prostate cancer prior and planning to initiate ADT therapy

Description

Inclusion Criteria:

• Dx with prostate cancer and planned ADT therapy

Exclusion Criteria:

• Contraindication to MRI
• Limited life expectancy
• Inability to participate in exercise testing
• Severe functional impairment
• Chronic kidney disease 4 or worse
• Hgb < 9
• Use of anti-resorptive agent
• non-English speaking
• Bone metastasis

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal muscle strength changes with ADT by MRI	Absolute muscle fat concentration (% proton density fat fraction) following ADT therapy	24 weeks
Muscle mass changes with ADT treatment	Mass of the proximal quadriceps, gluteal and psoas muscles by MRI (cm2)	24 weeks
Myostatin levels following ADT therapy	Myostatin ug/ml	24 weeks
Volumetric density following ADT therapy	Measure hip bone density in cm3	24 weeks
Gait speed following ADT therapy	Gait speed measured in meters per minute	24 weeks
Grip Strength following ADT therapy	Grip strength in Kg	24 weeks

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Charles Y. C. Pak Foundation
• Investigators: Principal Investigator: Craig Rubin, MD, UT Southwestern; Principal Investigator: Orhan Oz, MD,PhD, UT Southwestern

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): November 29, 2020
• Study Completion (Actual): November 29, 2020

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: sarcopenia; bone loss; androgen deprivation therapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: STU 022017-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No