A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating DCVax(tm)-Prostate, Autologous Dendritic Cells Loaded With Recombinant PSMA for the Treatment of Metastatic Hormone Refractory Prostate Cancer

Inclusion Criteria

Inclusion Criteria

- Hormone refractory prostate cancer (HRPC) – progressive disease despite
androgen deprivation and serum testosterone <50ng/dL; progression defined as either:

1. Rising PSA over 6 months with at least a 50% increase between the 1st and 3rd
measurement, and the 3rd measurement >2.0 ng/ml; or

2. Progression of metastatic lesion on bone scan, or

3. Progression of lymph node metastasis by CT scan.

- Zubrod or ECOG performance status of 0-1.

- Three or fewer bone metastases on a bone scan with minimal symptoms.

- No lymph node lesions greater than 3.0 cm at longest diameter.

- Adequate hematological, hepatic and renal function.

Exclusion Criteria

- History of other active malignancy.

- Prior chemotherapy, radiation therapy, immunosuppressive or investigational therapy
for metastatic disease in previous 12 months.

- Strong opioids, immunosuppressives, megestrol acetate or other estrogenic hormones
(e.g., Saw Palmetto, PC-SPES) within 1 month prior to enrollment.

- Brain, liver, or lung metastases; uncontrolled heart, liver, lung, or renal diseases
or other serious illness.

- Prior splenectomy.

- History of severe asthma, anaphylaxis, or other serious adverse reactions to vaccines
or any of the antigens included in the skin test.

- History of moderate to severe lower limb lymphedema, or recent signs of deep venous
thrombosis (DVT) or thrombo-embolic disease, or impending stroke.

- History of immunodeficiency or autoimmune disease; positive HIV, HbsAg or anti-HCV.

- Impending untreated spinal cord compression or urinary outlet obstruction.

- Any medication that might affect immune function. (Exceptions: Nonprescription doses
of NSAIDS; acetaminophen or aspirin; low doses of antihistamine therapy; normal range
doses of vitamins; and H2 blockers).