Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug |
|
| |
| Abiraterone acetate |
| Measure | Description | Time Frame |
|---|---|---|
| Change in VO2peak from baseline with abiraterone, enzalutamide or sipuleucel-T at week 21 | baseline, 21 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Compare VO2peak with patient- and physician reported functional status | 21 weeks | |
| Evaluate the variability of CPET in all arms | 2 weeks |
Not provided
Inclusion Criteria:
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 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:
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
Not provided
Not provided
Not provided
Duke clinics patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Harrison, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Sipuleucel-T | Drug |
|
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C540278 | enzalutamide |
| D000069501 | Abiraterone Acetate |
| C511774 | sipuleucel-T |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided