Clinical trial · Observational
Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer
Investigating Bone and Skeletal Muscle Interaction in Men With Prostate Cancer Treated With Androgen Deprivation Therapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Skeletal muscle strength changes with ADT by MRI
- timeFrame
- 24 weeks
- description
- Absolute muscle fat concentration (% proton density fat fraction) following ADT therapy
- measure
- Muscle mass changes with ADT treatment
- timeFrame
- 24 weeks
- description
- Mass of the proximal quadriceps, gluteal and psoas muscles by MRI (cm2)
- measure
- Myostatin levels following ADT therapy
- timeFrame
- 24 weeks
- description
- Myostatin ug/ml
- measure
- Volumetric density following ADT therapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 55 Years
- Maximum age
- 89 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available