Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer

This is an interventional treatment trial for Prostate Cancer focused on measuring stage IV prostate cancer, recurrent prostate cancer Read More

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