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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)

22. december 2020 opdateret af: Duke University

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.

Studieoversigt

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

38

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Duke clinics patients

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andre navne:
  • 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.
Andre navne:
  • 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.
Andre navne:
  • Hævn

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in VO2peak from baseline with abiraterone, enzalutamide or sipuleucel-T at week 21
Tidsramme: baseline, 21 weeks
baseline, 21 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Compare VO2peak with patient- and physician reported functional status
Tidsramme: 21 weeks
21 weeks
Evaluate the variability of CPET in all arms
Tidsramme: 2 weeks
2 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. juli 2015

Primær færdiggørelse (Faktiske)

14. november 2018

Studieafslutning (Faktiske)

14. november 2018

Datoer for studieregistrering

Først indsendt

29. januar 2015

Først indsendt, der opfyldte QC-kriterier

29. januar 2015

Først opslået (Skøn)

3. februar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. december 2020

Sidst verificeret

1. december 2020

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Enzalutamid

3
Abonner