Clinical trial · Observational
Intramuscular Mechanisms of Androgen Deprivation-related Sarcopenia
- 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)
Prostate cancer (PCa) is the most common cancer among men and is even more common in the military and veteran population. For patients with advanced prostate cancer, the most common treatment includes lowering the levels of the hormone testosterone as much as possible. This is called "androgen deprivation therapy" or "ADT". Unfortunately, ADT also causes patients to be fatigued, weak and to loose muscle. This is often referred to as "sarcopenia" and it leads to falls, poor quality of life and higher risk of death. Currently, there is no treatment for sarcopenia because the investigators do not understand the mechanisms that cause it. The mitochondria is the part of the cells responsible for providing energy to muscles but to this date the investigators do not know if it is affected in prostate cancer patients with sarcopenia due to ADT. The overall goal of this proposal is to establish if the mitochondria is responsible for sarcopenia in patients with prostate cancer receiving ADT. The investigators will measure mitochondrial function, muscle mass and strength, and feelings of fatigue and quality of life in patients with prostate cancer before starting and after 6 months of ADT.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Androgen Deprivation Therapy | — | UNRESOLVED | — |
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GnRH agonist | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Lean body mass (LBM) change
- timeFrame
- Baseline to 3 months
- description
- Changes in LBM (kg) measured by X-ray densitometry (DEXA).
- measure
- Lean body mass (LBM) change
- timeFrame
- Baseline to 6 months
- description
- Changes in LBM (kg) measured by X-ray densitometry (DEXA).
Secondary outcomes (11)
- measure
- Body composition change
- timeFrame
- Baseline to 6 months
- description
- Lean body mass and fat mass (kg) measured by dual energy x-ray absorptiometry (DEXA)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically, cytologically, or image based documented advanced or metastatic PCa initiating ADT with expected continuous treatment for a minimum of 6 months and willing/able to provide informed consent. * Willing and able to provide written informed consent prior to screening. Exclusion Criteria: * Liver disease (AST or ALT equal or more than 3x normal levels); * Renal failure (creatinine equal or more than 2.5 mg/dL); * Untreated thyroid disease, class III-IV CHF, AIDS; * Other cancer diagnosed within the past five years other than non-melanoma skin cancer; * Severe COPD requiring use of home O2; * Chronic, uncontrolled hypertension as judged by the Investigator (i.e., Baseline SBP \>150 mm Hg, DBP \>90 mm Hg) or a SBP \> 150 mm Hg or DBP \> 95 mm Hg at the time of screening or baseline; * An active, uncontrolled infection or cardiovascular disease including a recent myocardial infarction (MI), cerebrovascular accident (CVA), arrhythmias or unstable angina (\< 6 months); * Uncontrolled diabetes mellitus (as defined by a HbA1c equal or more than 9%); * Underlying muscular or neuromuscular disorder or neurologic deficit contributing to sarcopenia; * Enrolled in a clinical trial involving an investigational product or non-approved use of a drug/device or concurrently enrolled in medical research not scientifically or medically compatible with this study; * Current use (within one month) of testosterone, high dose steroids (20mg of prednisone/day for more than 1 month), or megestrol treatment for cancer within the previous 3 months; * Previous treatment with ADT other than oral anti-androgen at initiation of ADT; * Metal implants in the right limbs (non-MRI compatible metal stents, titanium pins/markers, etc.) or implanted cardiac pacemaker or other implanted non-MRI compatible cardiac device (e.g., stent); * A history of vascular problems (DVT, etc.)
References
Publications (1)
- BACKGROUNDShanely RA, Zwetsloot KA, Triplett NT, Meaney MP, Farris GE, Nieman DC. Human skeletal muscle biopsy procedures using the modified Bergstrom technique. J Vis Exp. 2014 Sep 10;(91):51812. doi: 10.3791/51812. PMID 25285722