Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate Cancer

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

The purpose of this study is to determine whether DCVAC/PCa added onto hormone therapy can improve PSA progression times for patients with Metastatic Prostate Cancer.

Use of vaccine to improve Prostate Specific Antigen (PSA) levels.

Inclusion Criteria:

• Male 18 years and older
• Histologically confirmed prostate adenocarcinoma
• Presence of bone or soft tissue metastasis (by CT or PET or MRI and/or scintigraphy)
• Androgen deprivation therapy using Luteinizing-hormone-releasing hormone ( LHRH) analogues commenced at least one month and at most three months prior randomization or orchiectomy performed at least one month and at most three months prior randomization
• Serum testosterone level at screening (≤ 1.7 nmol/l, resp. ≤ 50 ng/dL)
• Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

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