Phase II Study of DCVAC/PCa After Primary Radiotherapy for Patients With High Risk Localized Prostate Cancer

Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Localized High-risk Prostate Cancer After Primary Radiotherapy

The purpose of this study is to determine whether DCVAC/PCa added after radical primary prostatectomy can improve PSA progression times within 5 years for patients with high risk localized Prostate Cancer.

Treatment post radical primary prostatectomy Treatment post standard radiotherapy

Inclusion Criteria:

• Male 18 years and older
• Histologically confirmed localized prostate cancer of high risk or very high risk fulfilling at least one of the following: T3-T4 stage or Gleason Score 8-10 or PSA level above 20 ng/ml
• Indication for prostate cancer radical radiotherapy
• Neo-adjuvant androgen androgen-deprivation therapy due to prostate cancer using Luteinizing-hormone-releasing hormone (LHRH) analogues ongoing for at least two months and not longer than 12 months prior randomization
• Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

• Primary surgical treatment of prostate cancer
• Prior or ongoing chemotherapy for prostate cancer
• Participation in other clinical study or administration of other evaluated drug within 30 day prior screening
• Unresolved lasting obstruction of urinary system
• Other uncontrolled inter-current illness
• Treatment with immunotherapy against Prostate Cancer
• Clinically significant cardiovascular disease
• History of primary immunodeficiency
• Active autoimmune disease requiring treatment