Prostate CancerNCT03386812
Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer
An observational study of Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 89 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 29 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 89 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with prostate cancer prior and planning to initiate ADT therapy
Who may be able to join
- Dx with prostate cancer and planned ADT therapy
Who cannot join
- Contraindication to MRI
- Limited life expectancy
- Inability to participate in exercise testing
- Severe functional impairment
- Chronic kidney disease 4 or worse
- Hgb < 9
Show all 9Show fewer
- Use of anti-resorptive agent
- non-English speaking
- Bone metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer Treated With Androgen Deprivation Therapy.
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.
Read the 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.
- Conditions
- Prostate Cancer
- Keywords
- androgen deprivation therapy, sarcopenia, bone loss
- Medical subject headings
- Prostatic Neoplasms, Sarcopenia, Bone Diseases, Metabolic
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle strength changes with ADT by MRI
Absolute muscle fat concentration (% proton density fat fraction) following ADT therapy
Measured: 24 weeks
Muscle mass changes with ADT treatment
Mass of the proximal quadriceps, gluteal and psoas muscles by MRI (cm2)
Measured: 24 weeks
Myostatin levels following ADT therapy
Myostatin ug/ml
Measured: 24 weeks
Volumetric density following ADT therapy
Measure hip bone density in cm3
Measured: 24 weeks
Gait speed following ADT therapy
Gait speed measured in meters per minute
Measured: 24 weeks
Grip Strength following ADT therapy
Grip strength in Kg
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start1 Oct 2017
- Primary completion29 Nov 2020
- Study completion29 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Charles Y. C. Pak Foundation
- Responsible party
- Principal investigator, Craig D Rubin, University of Texas Southwestern Medical Center
- Investigators
- Craig Rubin, MD, Principal investigator, UT SouthwesternOrhan Oz, MD,PhD, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386812
- Sponsor's protocol ID
- STU 022017-022
- Status last verified
- Jan 2021
- First submitted
- 12 Dec 2017
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer Treated With Androgen Deprivation Therapy.
- ClinicalTrials.gov ID
- NCT03386812
- Acronym / sponsor ID
- STU 022017-022
- Conditions
- Prostate Cancer
- Keywords
- androgen deprivation therapy, sarcopenia, bone loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Charles Y. C. Pak Foundation
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 29 Nov 2020 (actual)
- Study completion
- 29 Nov 2020 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 89 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with prostate cancer prior and planning to initiate ADT therapy
Key inclusion criteria (1 listed)
- Dx with prostate cancer and planned ADT therapy
Key exclusion criteria (9 listed)
- Contraindication to MRI
- Limited life expectancy
- Inability to participate in exercise testing
- Severe functional impairment
- Chronic kidney disease 4 or worse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Rubin, MD principal investigator
UT Southwestern
Orhan Oz, MD,PhD principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle strength changes with ADT by MRI (time frame: 24 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.