5538S-14 A031201 prostate

CTSU A031201: Phase III Trial of Enzalutamide versus Enzalutamide Abiraterone and Prednisone For Castration-Resistant Metastatic Prostate Cancer

Type of Study
Cancer (Oncology) - Prostate
Location
Swedish Cancer Institute
Short Description

Patients are randomized to one of two treatment groups: enzalutamide or enzalutamide, abiraterone and prednisone. Treatment will continue until disease progression or unacceptable toxicity. Patients are followed for clinical outcomes for a maximum of 5 years post study treatment.

Primary Objective: 
To compare the overall survival of patients with progressive metastatic castration-resistant prostate cancer (CRPC) treated with either enzalutamide only or enzalutamide with abiraterone (abiraterone acetate) and prednisone


Status
Temporarily Closed
Principal Investigator
Gary Goodman, MD
Eligibility Notes
  • Progressive castration-resistant metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
  • Patients must have progressive disease at study entry defined as one or more of the following three criteria that occurred while the patient was on androgen deprivation therapy. For patients enrolling on the basis of soft tissue or bone progression, the baseline scan must show progression relative to a comparison scan. If the comparison scan is not available, the baseline scan report must reference the previous scan to document progression.
  • No treatment with prior taxane-based chemotherapy for metastatic disease.
    • Patients who received prior taxane-based chemotherapy as neoadjuvant or adjuvant therapy for local disease, or who received taxane-based therapy in the PSA clinical (non-metastatic) state is allowable provided that the total duration of exposure was six cycles or less and chemotherapy was completed more than 6 months prior to registration.

    • Taxane-based chemotherapy that was aborted due to allergic reactions or intolerance to chemotherapy and therefore received one cycle of prior therapy is allowable
  • No prior enzalutamide, abiraterone or other novel antiandrogen or androgen synthesis inhibitor
  • No treatment with any of the following for prostate cancer within 4 weeks prior to enrollment:
    • Hormonal therapy (e.g., androgen receptor [AR] antagonists, 5 alpha reductase inhibitors, estrogens) Note: Treatment with bicalutamide and nilutamide within 6 weeks prior to enrollment is not allowed. Treatment with flutamide within 4 weeks prior to enrollment is not allowed. Treatment with all other gonadotropin-releasing hormone (GnRH) analogues or antagonists is allowed.
    • Chemotherapy
    • Biologic therapy
    • Investigational therapy
    • Immunotherapy
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 215-3086
Email
cancerresearch@swedish.org