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

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

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

Details

• Lead Sponsor: SOTIO a.s.
• Treatments: Goserelin; Hormones; Leuprolide

Criteria

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