Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer

NCT03386812 | Completed

• 1 other identifier: STU 022017-022
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

androgen deprivation therapy; sarcopenia; bone loss

Outcome Measures

Primary Outcomes (6)

• Skeletal muscle strength changes with ADT by MRI

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

  24 weeks

• Muscle mass changes with ADT treatment

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

  24 weeks

• Myostatin levels following ADT therapy

  Myostatin ug/ml

  24 weeks

• Volumetric density following ADT therapy

  Measure hip bone density in cm3

  24 weeks

• Gait speed following ADT therapy

  Gait speed measured in meters per minute

  24 weeks

• Grip Strength following ADT therapy

  Grip strength in Kg

  24 weeks

Eligibility Criteria

• Age: 55 Years - 89 Years
• Gender Eligibility Details: yes-based on self-representation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with prostate cancer prior and planning to initiate ADT therapy

You may qualify if:

• Dx with prostate cancer and planned ADT therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Charles Y. C. Pak Foundation: collaborator

Study Sites (1)

UT Southwestern

Dallas, Texas, 75390-8889, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Sarcopenia; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

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

Study Officials

• Craig Rubin, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

• Orhan Oz, MD,PhD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 29, 2017
• Study Start: October 1, 2017
• Primary Completion: November 29, 2020
• Study Completion: November 29, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)