Phase I Trial of PACE for Metastatic Prostate Cancer

Exclusion Criteria

• •1. Prior docetaxel for castration-resistant disease (prior docetaxel for castration-sensitive disease is allowed but not required).
• •2. Prior enzalutamide, abiraterone, cabazitaxel.
• •3. History of severe hypersensitivity reaction (≥grade 3) to docetaxel.
• •4. History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs.
• •5. Concomitant vaccination with yellow fever vaccine.
• •6. Prior investigational androgen synthesis or androgen receptor antagonists.
• •7. Prior hypersensitivity reaction to capsule components of enzalutamide including labrasol, butylated hydroxyanisole and butylated hydroxytoluene
• •8. Other non-chemotherapeutic investigational agents within 14 days (prior chemotherapy needs a ≥4 week washout).
• •9. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments).
• •10. Prior isotope therapy with Strontium-89, Samarium or radium-223.
• •11. Patients with a history of central nervous system metastases (brain, meninges, spinal cord).
• •12. Imminent risk of pathologic fracture or cord compression.
• •13. History of seizures, underlying brain injury with loss of consciousness, transient ischemic attack within 12 months, cerebrovascular accident, and brain arteriovenous malformations.
• •14. Uncontrolled severe intercurrent illness or medical conditions including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III and IV heart failure), unstable angina pectoris, uncontrolled diabetes mellitus, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or concurrent medications that alter cardiac conduction.