Back to resultsStudy to Allow for Second Treatment Cycle of DCVAC in Patients With Localized Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
Czechia
Study Type
Interventional
Intervention
Dendritic Cells DCVAC/PCa
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Radical Prostatectomy
Eligibility Criteria
Inclusion Criteria:
- Male 18 years and older
- Histologically confirmed prostate adenocarcinoma Stage pathological tumor-2 (pT2)
- Post radical Primary Prostatectomy
- Completion of DCVAC/PCa arm in Study SP003, without objective progression of the disease
Exclusion Criteria:
- Prior androgen deprivation therapy 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 Type
Experimental
Arm Label
DCVAC/PCa Arm
Arm Description
Dendritic Cells DCVAC/PCa Experimental therapy
Outcomes
Primary Outcome Measures
Safety evaluation of the second cycle of DCVAC
Safety evaluation of the second cycle of active cellular immunotherapy, which includes a second leukapheresis procedure, who after primary radical prostatectomy completed first cycle of active cellular immunotherapy in clinical trial SP003 without objective disease progression requiring additional anti-tumor therapy.
Secondary Outcome Measures
Time to Prostate Specific Antigen (PSA) Doubling Time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02137746
Brief Title
Study to Allow for Second Treatment Cycle of DCVAC in Patients With Localized Prostate Cancer
Official Title
Open-label, One-arm, Multi-centre Phase II Clinical Trial Treated With Second Cycle of Active Cellular Immunotherapy With DCVAC/PCa in Patients With Localized Prostate Cancer After Primary Radical Prostatectomy Without Objective Progression
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
March 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 assess the safety of the second cycle of DCVAC/PCa in patients who completed the first cycle of DCVAC/PCa in the clinical trial SP003 without an objective progression of the disease.
Detailed Description
Same as brief summary
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Radical Prostatectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DCVAC/PCa Arm
Arm Type
Experimental
Arm Description
Dendritic Cells DCVAC/PCa Experimental therapy
Intervention Type
Biological
Intervention Name(s)
Dendritic Cells DCVAC/PCa
Intervention Description
DCVAC/PCa Experimental therapy
Primary Outcome Measure Information:
Title
Safety evaluation of the second cycle of DCVAC
Description
Safety evaluation of the second cycle of active cellular immunotherapy, which includes a second leukapheresis procedure, who after primary radical prostatectomy completed first cycle of active cellular immunotherapy in clinical trial SP003 without objective disease progression requiring additional anti-tumor therapy.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Time to Prostate Specific Antigen (PSA) Doubling Time
Time Frame
52 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male 18 years and older
Histologically confirmed prostate adenocarcinoma Stage pathological tumor-2 (pT2)
Post radical Primary Prostatectomy
Completion of DCVAC/PCa arm in Study SP003, without objective progression of the disease
Exclusion Criteria:
Prior androgen deprivation therapy 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
Hradec Kralove
Country
Czechia
City
Jablonec nad Nisou
Country
Czechia
City
Novy Jicin
Country
Czechia
City
Olomouc
Country
Czechia
City
Prague 4
Country
Czechia
City
Prague 5
Country
Czechia
City
Uherske Hradiste
Country
Czechia
City
Usti nad Labem
Country
Czechia
12. IPD Sharing Statement
Learn more about this trial
Study to Allow for Second Treatment Cycle of DCVAC in Patients With Localized Prostate Cancer
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