Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer

Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Castrate-resistant Prostate Cancer

The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care therapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer

Inclusion Criteria:

• Men aged ≥ 18 years
• Histologically confirmed prostate cancer
• Presence of skeletal metastasis (by CT or PET or MRI)
• Disease progression documented by increasing PSA or two new lesions
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

Exclusion Criteria:

• Confirmed brain and/or leptomeningeal metastases
• Prior chemotherapy for prostate cancer
• Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
• Other uncontrolled intercurrent illness
• Treatment with immunotherapy against PCa
• Clinically significant cardiovascular disease
• Active autoimmune disease requiring treatment