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

• Status: Completed
• Trial end date: 2017-02-20
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SOTIO a.s.
• Treatments: Docetaxel

Criteria

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