Prostate Cancer Clinical Trial
Official title:
Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer Treated With Androgen Deprivation Therapy.
Verified date | January 2021 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | November 29, 2020 |
Est. primary completion date | November 29, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 55 Years to 89 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | Charles Y. C. Pak Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Skeletal muscle strength changes with ADT by MRI | Absolute muscle fat concentration (% proton density fat fraction) following ADT therapy | 24 weeks | |
Primary | Muscle mass changes with ADT treatment | Mass of the proximal quadriceps, gluteal and psoas muscles by MRI (cm2) | 24 weeks | |
Primary | Myostatin levels following ADT therapy | Myostatin ug/ml | 24 weeks | |
Primary | Volumetric density following ADT therapy | Measure hip bone density in cm3 | 24 weeks | |
Primary | Gait speed following ADT therapy | Gait speed measured in meters per minute | 24 weeks | |
Primary | Grip Strength following ADT therapy | Grip strength in Kg | 24 weeks |
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