Exercise Intervention for Pts With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or Enzalutamide

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized, Controlled Study of an Exercise Intervention Program for Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Either Abiraterone or Enzalutamide

Conditions
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Metastatic Castration Resistant Prostate Cancer (mCRPC)

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age Metastatic disease that has progressed despite castrate levels of testosterone (surgically or medically castrated, with testosterone levels of < 50 ng/dL) No prior chemotherapy Initiated therapy with either abiraterone plus a glucocorticoid or enzalutamide within the 3 months prior to randomization Ability to engage safely in moderate exercise as determined by their treating physician Not previously engaged in regular exercise training (>1-2 d/wk for > 30 min/d) in the past 6 months Be able to speak and read English Exclusion Criteria: Any condition that causes severe pain with exertion History of bone fractures 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 Acute or chronic respiratory disease Acute or chronic bone/joint/muscular abnormalities compromising their ability to exercise Neurological conditions that affect balance and, or muscle strength Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Intervention Arm<br>The exercise intervention will consist of a combination of aerobic (cardiovascular exercise) and strength training (emphasis of the intervention) 3 times per week for 12 weeks with each session lasting  1.5 hours. | Behavioral: Exercise<br> <br> |
| No Intervention: Non-Exercise Control Arm<br>Participants in the Non-Exercise Control Arm will not exercise for 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | DEXA (Dual-energy X-ray absorptiometry) scans will measure lean mass at baseline and after the 12-week intervention. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Castration Resistant Prostate Cancer, Prostate Cancer, mCRPC, Pilot Study, UNC Lineberger, Exercise