Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer

DISEASE CHARACTERISTICS:

• Histopathological documentation of prostate cancer

  • If no pathologic specimen is available, patients may enroll on study with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease

• Biochemical progression, as defined by the following:

  • A rise in PSA of ≥ 2 ng/mL above the nadir (for patients previously treated with definitive radiotherapy or cryotherapy)
  • Two consecutive rises in PSA > 0.3 ng/mL (for patients previously treated with radical prostatectomy)
• PSA ≤ 20 ng/mL
• Testosterone ≥ lower limit of normal
• Negative CT scan and bone scan for metastatic prostate cancer
• No clinically active brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status of 0-1
• Life expectancy ≥ 6 months
• Granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL
• Bilirubin ≤ 1.5 mg/dL OR total bilirubin ≤ 3.0 mg/dL (in patients with Gilbert's syndrome)
• AST and ALT ≤ 2.5 times upper limit of normal
• No other active malignancies within the past 60 months (with the exception of nonmelanoma skin cancer or carcinoma in situ of the bladder)
• No life-threatening illnesses

• No immunocompromised status due to any of the following:

  • HIV positivity

  • Active autoimmune diseases, such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjögren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome, or active Grave's disease

    • Patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function, including CNS, heart, lungs, kidneys, skin, or gastrointestinal tract, will be allowed
  • Other immunodeficiency diseases or iatrogenic immunodeficiency from drugs
• No other serious medical illness that would interfere with the patient's ability to carry out the treatment program
• No documented contraindication (allergy or severe reaction to BCG)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from all prior therapy, including surgery and radiotherapy (no toxicity ≥ grade 2)
• No prior chemotherapy

• No concurrent topical steroids (including steroid eye drops) or systemic steroids

  • Nasal or inhaled steroid use is permitted
• No concurrent medications used for urinary symptoms, including 5-alpha reductase inhibitors (finasteride and dutasteride)
• No concurrent alternative medications known to alter PSA (e.g., phytoestrogens or saw palmetto)
• No other concurrent hormonal therapy
• No other concurrent anticancer treatment, including chemotherapy, systemic glucocorticoids, radiotherapy, major surgical procedures for prostate cancer, or nonprotocol-related immunotherapy