Overview

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