Clinical trial NCT03386812: Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer
Official title: Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer Treated With Androgen Deprivation Therapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: androgen deprivation therapy
sarcopenia
bone loss
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Charles Y. C. Pak Foundation
First posted: 2017-12-29
Enrollment: 19
Sex: MALE
Minimum age (years): 55
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with prostate cancer prior and planning to initiate ADT therapy

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.

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.

Eligibility 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

Primary outcomes:
measure: Skeletal muscle strength changes with ADT by MRI
timeFrame: 24 weeks
measure: Muscle mass changes with ADT treatment
timeFrame: 24 weeks
measure: Myostatin levels following ADT therapy
timeFrame: 24 weeks
measure: Volumetric density following ADT therapy
timeFrame: 24 weeks
measure: Gait speed following ADT therapy
timeFrame: 24 weeks
measure: Grip Strength following ADT therapy
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
Study officials:
affiliation: UT Southwestern
name: Craig Rubin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UT Southwestern
name: Orhan Oz, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: