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Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Prostate Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT03386812
STU 022017-022

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

Male

Ages

55 to 89 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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