Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03386812 |
Recruitment Status
:
Recruiting
First Posted
: December 29, 2017
Last Update Posted
: December 29, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Prostate Cancer |
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 |

- Skeletal muscle strength changes with ADT by MRI [ Time Frame: 24 weeks ]Absolute muscle fat concentration (% proton density fat fraction) following ADT therapy
- Muscle mass changes with ADT treatment [ Time Frame: 24 weeks ]Mass of the proximal quadriceps, gluteal and psoas muscles by MRI (cm2)
- Myostatin levels following ADT therapy [ Time Frame: 24 weeks ]Myostatin ug/ml
- Volumetric density following ADT therapy [ Time Frame: 24 weeks ]Measure hip bone density in cm3
- Gait speed following ADT therapy [ Time Frame: 24 weeks ]Gait speed measured in meters per minute
- Grip Strength following ADT therapy [ Time Frame: 24 weeks ]Grip strength in Kg

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 55 Years to 89 Years (Adult, Senior) |
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 |
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

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
Contact: Craig Principal investigator, MD | 2146489012 | craig.rubin@utsouthwestern.edu | |
Contact: Teena Coordinator | 2146489012 | teena.geiger@utsouthwestern.edu |
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 |
Principal Investigator: | Craig Rubin, MD | UT Southwestern | |
Principal Investigator: | Orhan Oz, MD,PhD | UT Southwestern |
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: | December 29, 2017 |
Last Verified: | December 2017 |
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 |