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Prostate Cancer – NCI-07-C-0107, NCT00450463

Dr. Ravi A. Madan
Principal Investigator

NCI’s Center for Cancer Research (CCR) is currently conducting the following trial for patients with prostate cancer. Click on the trial below for additional details, including a summary of key eligibility criteria, study outline, and information on how to contact Dr. Madan and his staff directly.

A Randomized Phase II Trial Combining Vaccine Therapy With PROSTVAC/TRICOM and Flutamide vs. Flutamide Alone in Men With Androgen Insensitive, Non-Metastatic (D0.5) Prostate Cancer
NCI-07-C-0107, NCT00450463

    Patients will be randomized on a 1:1 basis to Arm I (flutamide alone) or Arm II (flutamide + vaccine).

    Arm I

    • Patients receive flutamide 250 mg orally 3 x daily (TID) beginning on Day 1

    Arm II

    • Flutamide 250 mg orally TID beginning on Day 1
    • PROSTVAC-V/TRICOM (vaccinia) subcutaneously on Day 1 of the first cycle only
    • Followed by monthly (every 4 weeks) boosting vaccinations with PROSTVAC-F/TRICOM (fowlpox) subcutaneously on Day 1 of each cycle
    • Sargramostim 100 mcg subcutaneously will be given at the vaccine site for 4 consecutive days starting on Day 1 of each vaccine cycle
    • Treatment repeats every 28 days

      After 3 months of therapy, patients receiving the flutamide alone (Arm I) may cross over to receive vaccine if they develop a rising PSA and scans are without metastatic disease.

        Why is this trial important?

        Adenocarcinoma of the prostate is the most common cancer diagnosis in American men and the second leading cause of cancer death. Many men receiving hormonal therapy for prostate cancer develop a rising PSA but have no evidence of disease on bone scan or CT scan. Currently, there is no standard of care for these patients. In a prior clinical study, we showed preliminary clinical data that combining hormone therapy with a vaccine targeting PSA may benefit patients with this stage prostate cancer. In our current trial, patients will be randomized to receive either flutamide alone (an FDA-approved pill that is active in prostate cancer) or in combination with a prostate cancer vaccine to determine if the addition of the vaccine can improve the outcome (prolong disease progression) compared with flutamide alone. The study will also seek to understand the immunologic effects of these treatments.

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