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

Inclusion Criteria:

- Male 18 years and older

- Histologically or cytologically confirmed prostate adenocarcinoma

- Presence of skeletal, and/or soft-tissue/visceral/nodal metastasis

- Disease progression despite Androgen Deprivation Therapy

- Maintenance of castrate conditions

- Life expectancy of at least 6 months based on Investigator´s judgment.

- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

- At least 4 weeks after surgery or radiotherapy

- A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy

- Recovery from primary local surgical treatment, radiotherapy or orchiectomy

Exclusion Criteria:

- Confirmed brain and/or leptomeningeal metastases

- Current symptomatic cord compression requiring surgery or radiation therapy

- Prior chemotherapy for prostate cancer

- Subjects who are not indicated for chemotherapy treatment with first line Standard of
Care chemotherapy (docetaxel and prednisone)

- Systemic corticosteroids at doses greater than 40mg hydrocortisone daily or equivalent
for any reason other than treatment of prostate cancer (PCa) within the previous 6
months

- Systemic immunosuppressive therapy for any reason

- Treatment with immunotherapy against PCa within the previous 6 months prior to
randomization

- Clinically significant cardiovascular disease

- Active autoimmune disease requiring treatment

- Uncontrolled co-morbidities

- Participation in a clinical trial using experimental therapy within the last 4 weeks
prior to randomization

- Participation in a clinical trial using immunological experimental therapy (e.g.
monoclonal antibodies, cytokines or active cellular immunotherapies) within the last 6
months prior to randomization