Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT03386812
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

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 Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-29
• Primary Completion: 2020-11-29
• Study Completion: 2020-11-29
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

Inclusion Criteria

• Dx with prostate cancer and planned ADT therapy

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

UT Southwestern; 🇺🇸 Dallas, Texas, United States