Status:
COMPLETED
Intramuscular Mechanisms of Androgen Deprivation-related Sarcopenia
Lead Sponsor:
Seattle Institute for Biomedical and Clinical Research
Collaborating Sponsors:
United States Department of Defense
University of Washington
Conditions:
Metastatic Prostate Cancer
Androgen Deprivation Therapy
Eligibility:
MALE
18-90 years
Brief Summary
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...
Detailed Description
Prostate cancer (PCa) is the most common cancer among men. Androgen deprivation therapy (ADT) is the standard treatment for advanced and metastatic PCa and nearly 400,000 men remain on androgen depriv...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
December 7 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03867357
Start Date
December 7 2018
End Date
September 1 2023
Last Update
September 4 2024
Active Locations (1)
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1
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, United States, 98108