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Completed

NCT Number: NCT02353715

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male age ≥ 18 years
  • Histologically-confirmed adenocarcinoma of the prostate
  • Surgically or medically castrated
  • 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.
  • ECOG performance status 0 or 1
  • Able to read and understand English, in the opinion of the treating provider, well enough to complete the study questionnaires
  • Able to comply with study requirements
  • Successful completion of a CPET in the opinion on the investigator

Exclusion criteria

  • Subjects who have had any surgical procedure (i.e. TURP, etc.) within 4 weeks prior to entering the study.
  • Subjects receiving treatment with BOTH abiraterone and enzalutamide
  • For Arm C (sipuleucel-T) only:
  • subjects receiving abiraterone or enzalutamide concomitantly with sipuleucel-T should only be enrolled on Arm A or Arm B, as appropriate.
  • subjects who have received prior sipuleucel-T
  • Subjects who are receiving any other investigational agents (i.e. enzalutamide or abiraterone plus an investigational drug).
  • 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.
  • Significant cardiovascular disease, including:
  • 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.
  • Uncontrolled hypertension
  • Myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug
  • History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) within 12 months of first dose of study drug
  • Uncontrolled cardiac arrhythmias
  • Coronary or peripheral artery bypass graft within 6 months of first dose of study drug
  • History of CVA, TIA, or rest claudication within 6 months of first dose of study drug
  • 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
  • Known or suspected brain metastasis or leptomeningeal disease

Treatment and study plan

Enzalutamide

Drug

Other names: Xtandi

Abiraterone Acetate

Drug

Other names: Zytiga

Sipuleucel-T

Drug

Other names: Provenge

Primary outcomes

  1. Change in VO2peak from baseline with abiraterone, enzalutamide or sipuleucel-T at week 21

    Time frame: baseline, 21 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study 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

Acronym: PEAX

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 3, 2015
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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