A Safety and Feasibility Study of Active Immunotherapy in Patients With Metastatic Prostate Carcinoma Using Autologous Dendritic Cells Pulsed With Antigen Encoded in Amplified Autologous Tumor RNA

Inclusion Criteria: The patient has a histologic or clinically confirmed prostate adenocarcinoma (Stage D1-D3 metastatic with regional lymphatic, bone, visceral, or soft tissue metastases). (Transitional cell and small cell carcinomas of prostate origin are excluded.) The patient has a karnofsky performance status greater than or equal to 70%. Estimated life expectancy > 6 months The patient has adequate hematologic function with: WBC>=3000mm3, Hemoglobin>=9mg/dl, Platelets>=100,000/mm3 The patient has adequate renal and hepatic function with: serum creatinine < 2.5mg/dl bilirubin < 2.0 mg/dl The patient has adequate coagulation parameters with: PT = 11.3-13.3 sec PTT = 20.1-32.9 sec For patients who receive medical gonadal androgen suppression, the patient may continue hormonally ablative therapy with LHRH analogues only (i.e. Gosereline or Leuprolide). Testosterone level must be <50 mg/l. For patients who receive oral nonsteroidal antiandrogen therapy (i.e.flutamide or bicalutamide) and experience a rising PSA: a 4 week period of observation must be completed following discontinuation of the nonsteroidal antiandrogen prior to entry. The patient has the ability to understand and provide signed inform consent that fulfills Institutional Review Board guidelines. The patient has the ability to return to Duke University Medical Center for adequate follow-up as required by this protocol. Exclusion Criteria: The patient is receiving concurrent chemotherapy, radiation therapy, or immunotherapy. There must be at least 4 weeks (12 weeks if prior therapy included 89-Strontium) between any prior therapy and study entry. Patients must have recovered from all acute toxicities from prior treatment. The patient has previously irradiated or new CNS (central nervous system) metastases. (Pre-enrollment head CT is not required if not indicated by clinical signs or symptoms.) The patient has a history of autoimmune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. The patient has a serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the P.I. to constitute an unwarranted high risk for investigational drug treatment. The patient has a serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the P.I. to constitute an unwarranted high risk for investigational drug treatment. The patient has a medical or psychological impediment to probable compliance with the protocol. The patient has a concurrent second malignancy other than non-melanoma skin cancer, or controlled superficial bladder cancer. The patient has an active acute or chronic infection, including symptomatic urinary tract infection, HIV, or viral hepatitis. The patient is receiving oral or steroid therapy (or other immunosuppressive agents such as azathioprine or cyclosporine A). There must be 6 weeks between discontinuation of any steroid therapy and study enrollment. The patient has inadequate peripheral vein access to perform leukapheresis.