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Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03386812
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
Charles Y. C. Pak Foundation
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Description
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Brief 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.

Condition or disease
Prostate Cancer

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer Treated With Androgen Deprivation Therapy.
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   yes-based on self-representation
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men with prostate cancer prior and planning to initiate ADT therapy
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386812


Contacts
Contact: Craig Principal investigator, MD 2146489012 craig.rubin@utsouthwestern.edu
Contact: Teena Coordinator 2146489012 teena.geiger@utsouthwestern.edu

Locations
United States, Texas
UT Southwestern Recruiting
Dallas, Texas, United States, 75390-8889
Contact: Teena Geiger    214-648-9012    teena.geiger@utsouthwestern.edu   
Contact: Allison Beaver, RN    214-645-8788    Allison.Beaver@UTSouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Charles Y. C. Pak Foundation
Investigators
Principal Investigator: Craig Rubin, MD UT Southwestern
Principal Investigator: Orhan Oz, MD,PhD UT Southwestern
More Information
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03386812     History of Changes
Other Study ID Numbers: STU 022017-022
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Texas Southwestern Medical Center:
androgen deprivation therapy
sarcopenia
bone loss

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs