Men With Metastatic Castrate-Resistant Prostate Cancer Treated With Either Sipuleucel-T (Provenge®), Abiraterone Acetate (Zytiga®) or Enzalutamide (Xtandi®) Undergoing Cardiopulmonary EXercise Testing



Status:Completed
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/9/2019
Start Date:July 7, 2015
End Date:November 14, 2018

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PEAX: Men With Metastatic Castrate-Resistant Prostate Cancer Treated With Either Sipuleucel-T (Provenge®), Abiraterone Acetate (Zytiga®) or Enzalutamide (Xtandi®) Undergoing Cardiopulmonary EXercise Testing

This is a pilot exercise physiology and quality of life study of subjects receiving standard
of care therapy for their prostate cancer using FDA-approved drugs per their labeling
(abiraterone, enzalutamide, or sipuleucel-T). Subjects with progressive, asymptomatic or
minimally symptomatic mCRPC scheduled to be treated with either enzalutamide or abiraterone
acetate for ≥3 months or a course of sipuleucel-T will be allocated to one of the treatments
arms, according to the treatment chosen by the treating physician.


Inclusion Criteria:

1. Male age ≥ 18 years

2. Histologically-confirmed adenocarcinoma of the prostate

3. Surgically or medically castrated

4. Starting either enzalutamide or abiraterone for at least 12 weeks OR starting a course
of sipuleucel-T. Subjects being treated concomitantly with abiraterone or enzalutamide
plus sipuleucel-T are eligible and should be enrolled on Arm A or Arm B, as
appropriate.

5. ECOG performance status 0 or 1

6. Able to read and understand English, in the opinion of the treating provider, well
enough to complete the study questionnaires

7. Able to comply with study requirements

8. Successful completion of a CPET in the opinion on the investigator

Exclusion Criteria:

1. Subjects who have had any surgical procedure (i.e. TURP, etc.) within 4 weeks prior to
entering the study.

2. Subjects receiving treatment with BOTH abiraterone and enzalutamide

3. For Arm C (sipuleucel-T) only:

1. subjects receiving abiraterone or enzalutamide concomitantly with sipuleucel-T
should only be enrolled on Arm A or Arm B, as appropriate.

2. subjects who have received prior sipuleucel-T

4. Subjects who are receiving any other investigational agents (i.e. enzalutamide or
abiraterone plus an investigational drug).

5. Subjects with any of the following absolute contraindications to maximal exercise
testing as recommended by the American Thoracic Society and the exercise testing
guidelines for cancer subjects, in the opinion of the treating provider: (a) acute
myocardial infarction (3-5 days), (b) unstable angina, (c) uncontrolled arrhythmias
causing symptoms or hemodynamic compromise, (d) syncope, (e) acute endocarditis, (f)
acute myocarditis or pericarditis, (g) uncontrolled heart failure, (h) acute pulmonary
embolus or pulmonary infarction, (i) thrombosis of lower extremities, (j) suspected
dissecting aneurysm, (k) uncontrolled asthma, (l) pulmonary edema, (m) room air
desaturation at rest <85%, (n) respiratory failure, (o) acute noncardiopulmonary
disorder that may affect exercise performance or be aggravated by exercise, (p) mental
impairment leading to inability to cooperate, and (q) extensive bone metastases.

6. Significant cardiovascular disease, including:

1. Symptomatic left ventricular dysfunction or known baseline left ventricular
ejection fraction (LVEF) by multigated acquisition scan (MUGA) or echocardiogram
(ECHO) of < lower limit of institutional normal (LLN). "Symptomatic" is defined
as New York Heart Association (NYHA) Class II or greater. Note: MUGA and ECHCO do
NOT need to be measured to establish eligibility for this study.

2. Uncontrolled hypertension

3. Myocardial infarction, severe angina, or unstable angina within 6 months prior to
administration of first dose of study drug

4. History of serious ventricular arrhythmia (i.e., ventricular tachycardia or
ventricular fibrillation) within 12 months of first dose of study drug

5. Uncontrolled cardiac arrhythmias

6. Coronary or peripheral artery bypass graft within 6 months of first dose of study
drug

7. History of CVA, TIA, or rest claudication within 6 months of first dose of study
drug

7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

8. Known or suspected brain metastasis or leptomeningeal disease
We found this trial at
1
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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