Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy
- 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
- Scans must be obtained within 6 weeks of entry into the trial (initiation of
- Written informed consent.
- Age >/= 18 years.
- Required laboratory values [obtained within 2 weeks of study entry (initiation of
- 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
- PSA can be used as an eligibility criterion must be drawn within 28 days prior to
injection number 1 and will be redrawn on Day 1 for use as a baseline value.
- Candidates for salvage radiation therapy unless the patient refuses.
- 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 the last 3 months is not allowed.
- No-pre-existing malignancies that required treatment within the past 5 years except
for basal or squamous cell cancers of the skin.
- Prior systemic therapies for prostate cancer not allowed (hormonal therapy, including
but not limited to LHRH agonists, antiandrogens, ketoconazole or chemotherapy -
mitoxantrone/taxanes/estramustine, etc.) except when patients stopped hormone therapy
two or more years prior to enrollment and currently have normal testosterone levels;
patients in Arm B, undergoing androgen depletion therapy during the vaccination will
- Prior participation in any vaccine studies for non-infectious diseases.
- The inability to understand the language and the clinical protocol.
- Allergy or religious objection to pork products; Gelfoam is produced from pork.