A Phase II Immunotherapeutic Trial: Combination Androgen Ablative Therapy Treatment for Advanced Prostate Cancer
Abstract
The objectives of this study are to test whether CTLA 4 blockade + AA therapy canenhance clinical treatment responses in advanced prostate cancer patients relative to AA therapy alone. Study patients are randomized to 3 months of combined AA therapy + MDX-010 or versus AA therapy alone. To date, 46 patients have been enrolled and 42 randomized per protocol. An additional 84 patients have been screened and deemed ineligible for study. 29 patients now have sufficient follow-up to assess if any treatment effects may be occurring. In general, patients receiving combined AA + MDX-010 have exhibited greater PSA responses than patients receiving AA therapy alone. We have also observed that MDX-010 does not likely affect initial testosterone production but may delay testosterone recovery. Our preliminary studies also indicate atypical and favorable responses to combined MDX-010 + AA therapy including reversal of rising PSA, rapid resolution of obstructive urinary pathology and dramatic tumor downstaging resulting in unexpected 1 year disease-free patient status. Based on these preliminary observations, we believe that combined AA + MDX-010 treatment may encompass a promising approach to improve advanced prostate cancer treatment.
Document Details
- Document Type
- Technical Report
- Publication Date
- Mar 01, 2008
- Accession Number
- ADA485391
Entities
People
- Eugene D. Kwon
Organizations
- Mayo Clinic