Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Castrate-resistant Prostate Cancer
2 other identifiers
interventional
60
1 country
10
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 prostate-cancer
Started Feb 2012
Typical duration for phase_2 prostate-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 24, 2014
CompletedFirst Posted
Study publicly available on registry
April 7, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2017
CompletedMay 24, 2017
June 1, 2015
2.1 years
March 24, 2014
May 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival rate
135 weeks
Secondary Outcomes (5)
Radiographic Progression Free Survival
135 weeks
Duration to Prostate Specific Antigen (PSA) Progression
135 weeks
Changes in Quality of Life (QOL) assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
0, 10, 22, 37, 53, 65 weeks
Changes in Pain assessed by EORTC QLQ-C30
0, 10, 22, 37, 53, 65 weeks
Incidence of Adverse Events
135 weeks
Study Arms (2)
DCVAC/PCa add on to Standard of Care
EXPERIMENTALCombination therapy with Dendritic Cells DCVAC/PCa and Standard of Care
Standard of Care
ACTIVE COMPARATORDocetaxel as an Active Comparator
Interventions
DCVAC/PCa is the experimental therapy added on to Docetaxel
Docetaxel is Standard of Care First Line Chemotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SOTIO a.s.lead
Study Sites (10)
Unknown Facility
Brno, Czechia
Unknown Facility
Hradec Králové, Czechia
Unknown Facility
Jihlava, Czechia
Unknown Facility
Liberec, Czechia
Unknown Facility
Nová Ves pod Pleší, Czechia
Unknown Facility
Olomouc, Czechia
Unknown Facility
Ostrava, Czechia
Unknown Facility
Prague, Czechia
Unknown Facility
Ústí nad Labem, Czechia
Unknown Facility
Zlín, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tomas Scheiner, PhD
Sotio Biotech Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2014
First Posted
April 7, 2014
Study Start
February 1, 2012
Primary Completion
March 1, 2014
Study Completion
February 20, 2017
Last Updated
May 24, 2017
Record last verified: 2015-06