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

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 1170
• Participant gender: Male

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sotio a.s.
• Treatments: Docetaxel; Prednisone
• Last Updated: 2016-11-15

Criteria

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