A Phase II Immunotherapeutic Trial: Combination Androgen Ablative Therapy and CTLA-4 Blockade as a Treatment for Advanced Prostate Cancer
Abstract
This is an open-label, two-center, randomized phase II trial in which 108 patients with newly diagnosed advanced prostate cancer will be prospectively enrolled onto study. Patients with T3, NO, MX prostate cancer or patients with any T stage, Ni (defined as a single positive lymph node 2cm or less in size) and/or limited skeletal metastases will be considered for study inclusion. Limited skeletal metastases is defined as <3 metastatic lesions on bone scan. Patients must have undergone diagnosis and staging of their prostate cancer within 120 days of enrollment. Upon enrollment patients will be immediately randomized to receive either: i) 3 months of concurrent AA therapy + MDX-OlO (treatment group) or ii) 3 months of initial AA therapy alone (control group). Fifty four patients will be randomized at the Mayo Clinic, while the remaining 54 patients will be randomized at the University of California-San Francisco Comprehensive Cancer Center. Equal numbers of control and treatment group patients will be enrolled onto study at these two institutions over a period of eighteen months.
Document Details
- Document Type
- Technical Report
- Publication Date
- Dec 01, 2005
- Accession Number
- ADA469532
Entities
People
- Eugene D. Kwon
Organizations
- Mayo Clinic