Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer Treated With Androgen Deprivation Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Skeletal muscle strength changes with ADT by MRI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 89 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Dx with prostate cancer and planned ADT therapy
排除标准
- •Contraindication to MRI
- •Limited life expectancy
- •Inability to participate in exercise testing
- •Severe functional impairment
- •Chronic kidney disease 4 or worse
- •Use of anti-resorptive agent
- •non-English speaking
- •Bone metastasis
结局指标
主要结局
Skeletal muscle strength changes with ADT by MRI
时间窗: 24 weeks
Absolute muscle fat concentration (% proton density fat fraction) following ADT therapy
Muscle mass changes with ADT treatment
时间窗: 24 weeks
Mass of the proximal quadriceps, gluteal and psoas muscles by MRI (cm2)
Myostatin levels following ADT therapy
时间窗: 24 weeks
Myostatin ug/ml
Volumetric density following ADT therapy
时间窗: 24 weeks
Measure hip bone density in cm3
Gait speed following ADT therapy
时间窗: 24 weeks
Gait speed measured in meters per minute
Grip Strength following ADT therapy
时间窗: 24 weeks
Grip strength in Kg
次要结局
未报告次要终点
研究者
Craig D Rubin
Professor of Medicine
University of Texas Southwestern Medical Center