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

Inclusion Criteria

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
- 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
- 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.