Description: |
A randomized, phase II trial to determine if treatment with a prostate cancer vaccine plus flutamide is more effective than flutamide alone in delaying disease progression in patients with androgen-insensitive, non metastatic prostate cancer. After 3 months of therapy, patients receiving flutamide alone may cross over to receive vaccine if they develop a rising PSA and scans show no sign of disease spread. Patients receiving flutamide plus vaccine stop flutamide and may continue vaccine therapy. At this point patients may continue to receive treatment until the disease progresses or PSA levels rise. The objectives of this study are to determine if use of a combination of vaccine plus flutamide improves time to treatment failure compared to flutamide alone and to determine preliminary evidence of any patterns of immunologic effects which differ by treatment, including the immunologic effects of flutamide withdrawal on patients continuing on vaccine following a rising PSA on flutamide. |
Link: |
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Site: |
NCI |
Principal Investigator: |
Ravi Madan |