Back to resultsPhase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
Primary Purpose
Prostate Cancer, Prostate Cancer Metastatic
Status
Completed
Phase
Phase 2
Locations
Czechia
Study Type
Interventional
Intervention
Dendritic Cells DCVAC/PCa
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Immunotherapy, Metastatic, Castrate Resistant, Prostate Cancer, Biological, Vaccine
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DCVAC/PCa add on to Standard of Care
Standard of Care
Arm Description
Combination therapy with Dendritic Cells DCVAC/PCa and Standard of Care
Docetaxel as an Active Comparator
Outcomes
Primary Outcome Measures
Survival rate
Secondary Outcome Measures
Radiographic Progression Free Survival
Duration to Prostate Specific Antigen (PSA) Progression
Changes in Quality of Life (QOL) assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Changes in Pain assessed by EORTC QLQ-C30
Incidence of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02105675
Brief Title
Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (Actual)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
February 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SOTIO a.s.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Cancer Metastatic
Keywords
Immunotherapy, Metastatic, Castrate Resistant, Prostate Cancer, Biological, Vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DCVAC/PCa add on to Standard of Care
Arm Type
Experimental
Arm Description
Combination therapy with Dendritic Cells DCVAC/PCa and Standard of Care
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Docetaxel as an Active Comparator
Intervention Type
Biological
Intervention Name(s)
Dendritic Cells DCVAC/PCa
Intervention Description
DCVAC/PCa is the experimental therapy added on to Docetaxel
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
taxotere
Intervention Description
Docetaxel is Standard of Care First Line Chemotherapy
Primary Outcome Measure Information:
Title
Survival rate
Time Frame
135 weeks
Secondary Outcome Measure Information:
Title
Radiographic Progression Free Survival
Time Frame
135 weeks
Title
Duration to Prostate Specific Antigen (PSA) Progression
Time Frame
135 weeks
Title
Changes in Quality of Life (QOL) assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Time Frame
0, 10, 22, 37, 53, 65 weeks
Title
Changes in Pain assessed by EORTC QLQ-C30
Time Frame
0, 10, 22, 37, 53, 65 weeks
Title
Incidence of Adverse Events
Time Frame
135 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas Scheiner, PhD
Organizational Affiliation
Sotio Biotech Inc.
Official's Role
Study Director
Facility Information:
City
Brno
Country
Czechia
City
Hradec Kralove
Country
Czechia
City
Jihlava
Country
Czechia
City
Liberec
Country
Czechia
City
Nova Ves pod Plesi
Country
Czechia
City
Olomouc
Country
Czechia
City
Ostrava
Country
Czechia
City
Praha 10
Country
Czechia
City
Praha 4
Country
Czechia
City
Praha 5
Country
Czechia
City
Praha 8
Country
Czechia
City
Usti nad Labem
Country
Czechia
City
Zlin
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
possibly shared on EMA website
Learn more about this trial
Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
We'll reach out to this number within 24 hrs