Figure 1. Study design.

The DCVAC/PCa treatment consisted of a median twelve doses of 1 × 10⁷ dendritic cells injected s.c. The treatment comprised an initial 7 days of metronomic cyclophosphamide administration 50 mg p.o. and 2 subsequent doses of DCVAC/PCa. Patients then started docetaxel (75 mg/m²) and prednisone (5 mg twice daily) treatment, which was administered every 3 weeks; DCVAC/PCa was then given every 6 weeks up to the maximum number of doses manufactured from one leukapheresis. Imiquimod 5% (Aldara® 5% drm cream) was applied locally 24 hours before and after each DCVAC/PCa administration. Immunomonitoring (IM) was evaluated after the first and twelfth doses of DCVAC/PCa. Clinical evaluation (CE) was performed after every single DCVAC/PCa dose.