Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer (APP22)

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 bilirubin <1.5 mg/dl.
• 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.