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OpenTrials
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NCT Number: NCT03386812

Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Atrophy Bone Diseases Bone Diseases, Metabolic Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metabolic Diseases Muscular Atrophy Musculoskeletal Diseases Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Sarcopenia Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

55 year–89 year

Sex eligibility

Male

Study type

Observational

Primary location

UT Southwestern

Dallas, Texas, 75390-8889, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Skeletal muscle strength changes with ADT by MRI

    Time frame: 24 weeks

    Absolute muscle fat concentration (% proton density fat fraction) following ADT therapy

  2. Muscle mass changes with ADT treatment

    Time frame: 24 weeks

    Mass of the proximal quadriceps, gluteal and psoas muscles by MRI (cm2)

  3. Myostatin levels following ADT therapy

    Time frame: 24 weeks

    Myostatin ug/ml

  4. Volumetric density following ADT therapy

    Time frame: 24 weeks

    Measure hip bone density in cm3

  5. Gait speed following ADT therapy

    Time frame: 24 weeks

    Gait speed measured in meters per minute

  6. Grip Strength following ADT therapy

    Time frame: 24 weeks

    Grip strength in Kg

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Charles Y. C. Pak Foundation

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 29, 2017
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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