Prostate cancer is one of the most common cancer found in man. For patients with hormone-refractory, metastatic tumour no effective therapy is available and prognosis is very poor. Therefore we designed a clinical study using a novel approach for the treatment of patients with advanced stages of prostate cancer. Preliminary data concerning dendritic cell (DC) based vaccination revealed promising results but the clinical relevance is still questioned. Thus, we decided to develop a clinical protocol for the treatment of 12 patients with hormone-refractory prostate carcinoma using prostate-specific antigen (PSA)-derived peptides loaded on DC.