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

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ClinicalTrials.gov Identifier: NCT02353715
Recruitment Status : Active, not recruiting
First Posted : February 3, 2015
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment
Prostate Cancer Drug: Enzalutamide Drug: Abiraterone acetate Drug: Sipuleucel-T

Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PEAX: Men With Metastatic Castrate-Resistant Prostate Cancer Treated With Either Sipuleucel-T (Provenge®), Abiraterone Acetate (Zytiga®) or Enzalutamide (Xtandi®) Undergoing Cardiopulmonary EXercise Testing
Study Start Date : May 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Enzalutamide
Subjects will be administered enzalutamide per standard of care under the care of their treating physician. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline and 21 weeks.
Drug: Enzalutamide
Other Name: Xtandi

Abiraterone
Subjects will be administered abiraterone acetate per standard of care under the care of their treating physician. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline and 21 weeks.
Drug: Abiraterone acetate
Other Name: Zytiga

Sipuleucel-T
Subjects will be administered sipuleucel-T per standard of care under the care of their treating physician. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline and 21 weeks.
Drug: Sipuleucel-T
Other Name: Provenge




Primary Outcome Measures :
  1. Change in VO2peak from baseline with abiraterone, enzalutamide or sipuleucel-T at week 21 [ Time Frame: baseline, 21 weeks ]

Secondary Outcome Measures :
  1. Compare VO2peak with patient- and physician reported functional status [ Time Frame: 21 weeks ]
  2. Evaluate the variability of CPET in all arms [ Time Frame: 2 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Duke clinics patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353715


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Michael Harrison, MD Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02353715     History of Changes
Other Study ID Numbers: Pro00058229
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Abiraterone Acetate
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors