Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer

Inclusion criteria:

* Men with prostate cancer who present with evidence of hormone refractory disease (D3).
* Men with a positive bone scan or a positive CT scan (with obvious soft tissue metastasis or lymph nodes \>1 cm), a PSA doubling time of \>/= 6 months, and a total PSA of \<10 ng/ml, and asymptomatic OR men with a negative bone scan and a negative CT scan with any PSA doubling time and asymptomatic.
* Scans must be obtained within 6 weeks of initiation of treatment.
* Written informed consent.
* Age \>/= 18 years.
* Required laboratory values (obtained within 2 weeks of initiation of treatment)
* Serum creatinine \</= 2.0 mg/dL
* Adequate hematologic function: granulocytes \>/= 1800 per mm3, platelets \>/= 100,000 per mm3, WBC \>/= 3700, and lymphocytes \>590.
* Adequate hepatocellular function: AST \<3x upper limit of normal and total bilirubin \<1.5 mg/dl (unless bilirubin elevation is consistent with Gilbert's syndrome).
* Castrate levels of testosterone of \</= 50 ng/ml.
* PSA can be used as an eligibility criterion must be drawn within 28 days prior to injection number 1 and will be drawn on Day 1 for use as a baseline value.

Exclusion criteria:

* Active or unresolved clinically significant infection.
* Parenteral antibiotics \<7 days prior to initiation of treatment.
* Evidence of prior or current CNS metastases. Specific imaging is not necessary in the absence of signs or symptoms.
* Co-morbid medical conditions which would result in a life expectancy (participation) of less than 1 year.
* Patients with compromised immune systems; congenital, acquired, or drug-induced (immunosuppressive agents) will be excluded from the study. Use of prednisone at doses higher than 10 mg daily (or equipotent steroid doses) for more than 7 days within 3 months of initiation of treatment is not allowed.
* Pre-existing malignancies that required treatment within the past 5 years except for basal or squamous cell cancers of the skin.
* Prior participation in any vaccine studies for non-infectious diseases.
* Prior chemotherapy, defined as prior cytotoxic chemotherapy for prostate cancer (or any cancer unless more than 5 years have elapsed). Examples of cytotoxic chemotherapy are mitoxantrone/prednisone and taxanes. Drugs such as Casodex or ketoconazole treatment must have been completed at least 6 weeks prior to initiation of treatment.
* The inability to understand the language and the clinical protocol.
* Allergy or religious objection to pork products; Gelfoam is produced from pork.