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 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 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.