Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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androgen deprivation therapy, sarcopenia, bone loss