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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-02-29

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.

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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.

Conditions

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Metastatic Castration Resistant Prostate Cancer (mCRPC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise Intervention Arm

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Non-Exercise Control Arm

Participants in the Non-Exercise Control Arm will not exercise for 12 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No