NCT03386812

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 19 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: Male
• Age: 55 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Timeline

• Start date: 2017-10-01
• Primary completion: 2020-11-29
• Completion: 2020-11-29
• First posted: 2017-12-29
• Last updated: 2021-01-15

Locations

1 site across 1 country: United States