A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge) for Asymptomatic Metastatic Hormome-Refractory Prostate Cancer

Inclusion Criteria

Inclusion Criteria include:

- Metastatic disease as evidenced by soft tissue and/or bony metastases.

- Baseline PSA value of at least 5 ng/mL. All subjects must have stable or rising PSA.

- Tumor progression after hormonal therapy.

- Hormonal therapy consisting of castration by orchiectomy or LHRH agonists for
treatment of prostate cancer. Castration levels of testosterone (< 50 ng/dL) must be
documented for all subjects including subjects who underwent orchiectomy as therapy
for cancer of the prostate.

- A subject is eligible if he initially responded to antiandrogen withdrawal (> 25%
decrease in PSA) but at the time of registration demonstrated tumor progression. A
subject is eligible if he failed to respond to antiandrogen withdrawal.

- Subjects have no cancer-related pain and do not regularly require analgesics for
cancer-related pain.

- ECOG Performance Status of 0 or 1.

- Life expectancy of at least 16 weeks.

- Adequate hematologic, renal, and liver function.

Exclusion Criteria include:

- Visceral organ metastases (e.g., liver, lung, brain) or cytologically positive
effusions (e.g., pleural effusions or ascites).

- Metastatic disease expected to be in need of radiation therapy within 4 months.

- Concurrent therapy with experimental agents.

- Systemic corticosteroids at doses greater than 40 mg hydrocortisone per day for any
reason other than treatment of prostate cancer within the previous 6 months without
prior approval.

Please note that there are additional eligibility criteria. The study center will
determine if you meet all of the criteria.