Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy APP21
Condition: Recurrent Prostate Cancer
MeSH terms: Prostatic Neoplasms; Recurrence
Intervention: Adenovirus/PSA Vaccine
Intervention description: 1x10E8pfu in Gelfoam subcutaneously on day 0, 30, 60
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Male
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: prostate cancer; vaccine; immunotherapy

Summary:

      The purpose of this study is to determine whether vaccination with the Ad/PSA vaccine will
      induce an anti-PSA immunity that will result in the destruction of the remaining prostate
      cancer cells.
    

Eligibility criteria:

        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.

        Exclusion Criteria:

          -  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
             be eligible.

          -  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.