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

UNC Lineberger Comprehensive Cancer Center

Status: Withdrawn

Conditions: Metastatic Castration Resistant Prostate Cancer (mCRPC)

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02130947

14-0177 (Other Identifier)

LCCC 1339

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Exercise Intervention Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise

Non-Exercise Control Arm

No Intervention group

Description:

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