Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy APP21

Inclusion Criteria

• •Men with prostate cancer who have received prior local therapy (radical prostatectomy or definitive radiation therapy) and have biochemical (PSA) relapse without evidence of radiographic or clinical metastatic disease.
• •For men who had prior prostatectomy, the surgery must have occurred at least 6 months prior to initiation of treatment.
• •For men who had prior definitive radiation therapy, radiation must have been completed at least 1 year prior to initiation of treatment.
• •Exhibit at least three separate rises in serum PSA, at least one month apart with differences \>/= 0.03 ng/ml and a total PSA of \>0.2 ng/ml.
• •Have a PSA doubling time of \>/= 6 months if the baseline serum PSA was \>2 ng/ml.
• •Negative bone scans.
• •Negative CT scans of abdomen and pelvis (no evidence of soft tissue lesions \>/= 1 cm).
• •Scans must be obtained within 6 weeks of entry into the trial (initiation of treatment).
• •Written informed consent.
• •Age \>/= 18 years.
• •Required laboratory values \[obtained within 2 weeks of study entry (initiation of treatment)\].
• •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 (unless bilirubin elevation is consistent with Gilbert's syndrome).
• •PSA used as an eligibility criterion must be drawn within 42 days prior to injection number 1 and will be redrawn on Day 1 for use as a baseline value.