NCT02130947

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

May 1, 2014

Last Update Submit

February 10, 2016

Conditions

Metastatic Castration Resistant Prostate Cancer (mCRPC)

Keywords

Metastatic Castration Resistant Prostate CancerProstate CancermCRPCPilot StudyUNC LinebergerExercise

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Exercise Intervention Arm

EXPERIMENTAL

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

Non-Exercise Control Arm

NO INTERVENTION

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

Interventions

ExerciseBEHAVIORAL
Exercise Intervention Arm

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Anthony C Hackney, Ph.D., D.Sc.

    University of North Carolina

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2014

First Posted

May 6, 2014

Study Start

April 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 11, 2016

Record last verified: 2016-02

Locations

US(1)