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

Not Applicable

Withdrawn

• Conditions: Metastatic Castration Resistant Prostate Cancer (mCRPC)
• Interventions: Behavioral: Exercise

• Registration Number: NCT02130947
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-01
• Study First Submitted QC: 2014-05-01
• Study First Posted: 2014-05-06
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-02-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Intervention Arm	Exercise	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States