Prostate CancerPEAXNCT02353715
Men With Metastatic Castrate-Resistant Prostate Cancer Treated With Either Sipuleucel-T (Provenge®), Abiraterone Acetate (Zytiga®) or Enzalutamide (Xtandi®) Undergoing Cardiopulmonary EXercise Testing
An observational study of Prostate Cancer, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Enzalutamide, Abiraterone acetate and Sipuleucel-T
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2015to 14 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Duke clinics patients
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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
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.
- Conditions
- Prostate Cancer
- Being tested
- Enzalutamide, Abiraterone acetate, Sipuleucel-T
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
Also called Xtandi
Abiraterone acetateDrug
Also called Zytiga
Sipuleucel-TDrug
Also called Provenge
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Enzalutamide | |
| 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. Receives: Drug: Abiraterone acetate | |
| 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. Receives: Drug: Sipuleucel-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2peak from baseline with abiraterone, enzalutamide or sipuleucel-T at week 21
Measured: baseline, 21 weeks
Secondary outcomes (2)
Compare VO2peak with patient- and physician reported functional status
Measured: 21 weeks
Evaluate the variability of CPET in all arms
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study start7 Jul 2015
- Primary completion14 Nov 2018
- Study completion14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Harrison, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353715
- Sponsor's protocol ID
- Pro00058229
- Acronym
- PEAX
- Status last verified
- Dec 2020
- First submitted
- 29 Jan 2015
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02353715
- Acronym / sponsor ID
- PEAX / Pro00058229
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 7 Jul 2015 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide | – | Drug: EnzalutamideSubjects 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. |
| Abiraterone | – | Drug: Abiraterone acetateSubjects 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. |
| Sipuleucel-T | – | Drug: Sipuleucel-TSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Duke clinics patients
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnzalutamideAlso: Xtandi | Drug | Enzalutamide |
| Abiraterone acetateAlso: Zytiga | Drug | Abiraterone |
| Sipuleucel-TAlso: Provenge | Drug | Sipuleucel-T |
Primary outcome
Change in VO2peak from baseline with abiraterone, enzalutamide or sipuleucel-T at week 21
Time frame: baseline, 21 weeks
2 secondary outcomes
Compare VO2peak with patient- and physician reported functional status
Time frame: 21 weeks
Evaluate the variability of CPET in all arms
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Harrison, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VO2peak from baseline with abiraterone, enzalutamide or sipuleucel-T at week 21 (time frame: baseline, 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.