Docetaxel and Prednisone With or Without Vaccine Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the prostate

  • Evidence of metastatic disease by the presence of soft tissue and/or bone metastases on CT scan of the abdomen and/or pelvis, or bone scintigraphy

• Castrate-resistant disease defined by the following:

  • Must have received standard-of-care androgen-deprivation treatment (ADT) (e.g., surgical castration, gonadotropin-releasing hormone [GnRH], or antagonist treatment)
  • Patients on concurrent GnRH analogue or antagonist must continue on this treatment throughout this study
  • Must have been treated with nonsteroidal antiandrogen with evidence of subsequent disease progression
  • Must have castration levels of testosterone (< 50 ng/dL) within the past 4 weeks

• Progressive disease while receiving ADT, defined by any 1 of the following:

  • At least 2 consecutive rises in serum PSA (each value ≥ 2.0 ng/mL) obtained at a minimum of 1-week intervals

  • Measurable disease with ≥ 50% increase in the sum of the cross products of all measurable lesions, or the development of new measurable lesions by RECIST

    • The greatest diameter of a target lymph node must be ≥ 2 cm with conventional techniques or ≥ 1 cm by spiral CT scan

  • Non-measurable (bone) disease consisting of ≥ 2 new areas of uptake by bone scan consistent with metastatic disease compared to previous imaging during castration therapy

    • Ambiguous results must be confirmed by other imaging modalities (e.g., X-ray, CT scan, or MRI)
• Presence of visceral metastases
• No known brain metastases
• Life expectancy ≥ 18 months by Halabi nomogram
• ECOG performance status 0-2
• WBC ≥ 2,000/mm^3
• ANC ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Creatinine ≤ 2.0 mg/dL
• AST and ALT ≤ 1.5 times upper limit of normal
• Total bilirubin normal
• Fertile patients must agree to use effective contraception before, during, and for ≥ 4 months after completion of study therapy

• No known infection with HIV 1 or HIV 2, HTLV-1, hepatitis B, or hepatitis C, or any other potentially immunosuppressive infection

  • Patients must have negative serologic testing for HIV, hepatitis B surface antigen, and hepatitis C

• No history of autoimmune disease requiring active immunosuppressive therapy or ≥ grade 2 organ dysfunction as a result of known autoimmune disease

  • Patients must have antinuclear antibody (ANA) titer < 1:320
• No other active malignancy except nonmelanoma skin cancer, carcinoma in situ of the bladder, or other adequately treated cancer that has been free of recurrence for ≥ 3 years
• No allergy to eggs
• No known intolerance or allergic reactions to docetaxel or compounds of similar chemical or biologic composition
• No known history of allergic or intolerable reaction to vaccinia virus vaccination (e.g., smallpox)

• Patients or close household contacts of patients cannot have close contact with persons with the following conditions within 3 weeks after potential vaccinia immunization:

  • History of eczema, active eczema or other acute, chronic, or exfoliative skin conditions, including Darier's disease (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or open wounds)
  • Pregnant or nursing women
  • Children under 3 years of age
  • Immunodeficient or immunosuppressed persons (e.g., HIV infection, or treated for other diseases with immunosuppressive agents)
  • Any other moderate or severe acute illness until the illness resolves

• None of the following conditions within the past 6 months:

  • Stroke
  • Myocardial infarction
  • Unstable angina
  • NYHA class II-IV congestive heart failure
  • Significant cardiomyopathy requiring treatment
• At least 4 weeks since prior nonsteroidal antiandrogen (e.g., flutamide) (6 weeks for bicalutamide or nilutamide)

• More than 4 weeks since prior and no concurrent therapy with any of the following:

  • Other systemic corticosteroids

    • Inhaled, intranasal, or topical corticosteroids allowed
    • No steroid eyedrops at least 2 weeks before and 4 weeks after protocol vaccination
  • PC-SPES
  • Saw palmetto
  • Megestrol
  • Ketoconazole

  • 5-α-reductase inhibitors

    • Patients on 5-α-reductase inhibitors for > 28 days may continue these agents throughout the study
    • May not start therapy with 5-α-reductase inhibitors during study therapy
  • Diethyl stilbestrol
  • Any other hormonal agent or supplement with possible anticancer activity
• More than 4 weeks since prior external-beam radiation therapy
• At least 4 weeks since any prior treatment and recovered
• More than 4 weeks since surgery

• More than 6 months since prior chemotherapy

  • Prior and/or concurrent bisphosphonates allowed
• More than 2 weeks since prior and no concurrent CYP3A4 substrates, inhibitors, or inducers
• No prior chemotherapy for metastatic prostate cancer
• No prior radiotherapy to > 30% of bone marrow
• No prior anticancer vaccine
• No prior splenectomy
• No other concurrent investigational agents or anticancer therapy other than androgen-deprivation treatment