Metastatic Castration Resistant Prostate Cancer (mCRPC)
Conditions
Keywords
Metastatic Castration Resistant Prostate Cancer, Prostate Cancer, mCRPC, Pilot Study, UNC Lineberger, Exercise
Brief summary
This randomized pilot study will be conducted in men with metastatic castration resistant prostate cancer (mCRPC) within 3 months of initiating abiraterone or enzalutamide. The purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in mCRPC patients who have recently started on additional androgen suppression therapy.
Detailed description
This randomized pilot study will be conducted in men with metastatic castration resistant prostate cancer (mCRPC) within 3 months of initiating abiraterone or enzalutamide. The purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in mCRPC patients who have recently started on additional androgen suppression therapy. The investigators will also explore the effects of the exercise training on biomarkers of inflammation-hormonal status and their potential association with changes in lean mass and function.
Interventions
BEHAVIORALExercise
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years of age 2. Metastatic disease that has progressed despite castrate levels of testosterone (surgically or medically castrated, with testosterone levels of \< 50 ng/dL) 3. No prior chemotherapy 4. Initiated therapy with either abiraterone plus a glucocorticoid or enzalutamide within the 3 months prior to randomization 5. Ability to engage safely in moderate exercise as determined by their treating physician 6. Not previously engaged in regular exercise training (\>1-2 d/wk for \> 30 min/d) in the past 6 months 7. Be able to speak and read English
Exclusion criteria
1. Any condition that causes severe pain with exertion 2. History of bone fractures 3. Active cardiovascular disease including any of the following: * New York Heart Association (NYHA) Grade II or greater congestive heart failure * History of myocardial infarction or unstable angina within 6 months prior to Day 1 * History of stroke or transient ischemic attack within 6 months prior to Day 1 4. Acute or chronic respiratory disease 5. Acute or chronic bone/joint/muscular abnormalities compromising their ability to exercise 6. Neurological conditions that affect balance and, or muscle strength 7. Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in lean mass between mCPRC patients undergoing a 12-week exercise intervention (intervention group) and mCPRC patients who do not undergo the exercise intervention (control group) | 12 weeks | DEXA (Dual-energy X-ray absorptiometry) scans will measure lean mass at baseline and after the 12-week intervention. |
Countries
United States
Outcome results
None listed