Phase I/II Study of Vaccination With Antigen Loaded Dendritic Cells (DCs) in Hormone-Refractory Prostate Cancer

Inclusion Criteria:

* histologically or cytologically proven prostatic carcinoma
* proven hormonal resistance: tumor progression after orchiectomy or during treatment with hormonal agents. Patients treated with antiandrogens, such as flutamide (Flucinom) or bicalutamide (Casodex), should have been discontinued the drug 6 weeks prior to the trial entry followed by no tumor response within this 6 weeks
* not amenable to curative therapy
* patients with measurable and non-measurable disease may be included. Bone lesions only are considered to be non-measurable
* two consecutive increases of prostate-specific antigen (PSA) should be documented over a previous reference value (N°1). The first increase in PSA (N°2) should occur a minimum of one week from the reference value and be confirmed (N°3). If this value is less than the previous value, the patient is still eligible if the next PSA(N°4) is found to be higher than the second PSA. Serum levels of prostate-specific antigen must be at least 10 microg/l
* Previous radiotherapy is allowed if it has been stopped 4 weeks or more before the trial treatment and did not involve lesions used to evaluate activity of the trial drugs
* one previous chemotherapy (including Estracyt) is allowed, but the chemotherapy should have been stopped at least 6 weeks before study entry
* age \>18 years
* performance status 0,1,2 (ECOG, Appendix I)
* no concurrent therapy with steroids
* no uncontrolled infections
* live expectancy more than 3 months
* Human leukocyte antigen (HLA)-Type has to be HLA\*A201
* neutrophile count \>1500/microl and thrombocytes \>100 000/microl
* creatinine \<1.5 of upper normal level
* adequate liver function with bilirubin \<2 of upper normal level, alanine aminotransferase (ALAT) and aspartate transamionase (ASAT) \< 3 x upper normal level
* absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
* before patient registration/randomization, informed consent must be given according to good clinical practice (GCP), and national/local regulations

Exclusion Criteria:

* serious concomitant disease (cardiac, pulmonary and others)
* brain metastasis
* previous splenectomy or radiotherapy to the spleen
* concurrent therapy with immunosuppressive drugs
* chronic immunosuppression (includes transplantation or HIV-infection) HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) (test required) or any other severe uncontrolled infection other neoplastic diseases except: curatively treated basal cell or squamous cell carcinoma of the skin or relapse free for more than 5 years after curative treatment of a neoplasm
* treatment with other investigational drugs during the last month
* severe autoimmune disease
* chemotherapy, radiotherapy or immunotherapy less than 6 weeks before study entry
* Ejection fraction (measured by echocardiography) \< 40%