Prostate Cancer Clinical Trial
Official title:
Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Combination With Hormone Therapy in Patients With Metastatic Prostate Cancer
Verified date | June 2015 |
Source | Sotio a.s. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 63 |
Est. completion date | June 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sotio a.s. |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with PSA Progression | 104 weeks | ||
Secondary | Proportion of patients with Progression of Disease | 0, 6, 16, 28, 40, 52, 65, 78, 91, 104 weeks | ||
Secondary | Frequency of Adverse Events | 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks | ||
Secondary | Frequency of Skeletal Related Events | 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks | ||
Secondary | Changes in Quality of Life (QOL) assessed by EORTC QLQ-C30 | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30 | 0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks | |
Secondary | Changes in Pain assessed by EORTC QLQ-C30 | Pain Scale from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30 | 0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks |
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