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

Withdrawn before enrolling · Not applicable

Conditions studied: Metastatic Castration Resistant Prostate Cancer (mCRPC)

In brief

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.

Key facts

Study ID

NCT02130947

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

0

Starts

2014-04-01

Expected to finish

2016-02-01

Last updated by the study team

2016-02-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• 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

Where it is running

• Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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