Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
NCT ID: NCT02105675
Last Updated: 2017-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2012-02-29
2017-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DCVAC/PCa add on to Standard of Care
Combination therapy with Dendritic Cells DCVAC/PCa and Standard of Care
Dendritic Cells DCVAC/PCa
DCVAC/PCa is the experimental therapy added on to Docetaxel
Standard of Care
Docetaxel as an Active Comparator
Docetaxel
Docetaxel is Standard of Care First Line Chemotherapy
Interventions
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Dendritic Cells DCVAC/PCa
DCVAC/PCa is the experimental therapy added on to Docetaxel
Docetaxel
Docetaxel is Standard of Care First Line Chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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SOTIO a.s.
INDUSTRY
Responsible Party
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Principal Investigators
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Tomas Scheiner, PhD
Role: STUDY_DIRECTOR
Sotio Biotech Inc.
Locations
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Brno, , Czechia
Hradec Králové, , Czechia
Jihlava, , Czechia
Liberec, , Czechia
Nová Ves pod Pleší, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Ústí nad Labem, , Czechia
Zlín, , Czechia
Countries
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Other Identifiers
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2011-004735-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP001
Identifier Type: -
Identifier Source: org_study_id
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