Study to Allow for Second Treatment Cycle of DCVAC in Patients With Localized Prostate Cancer
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
2 other identifiers
interventional
24
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 prostate-cancer
Started Dec 2013
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 12, 2014
CompletedFirst Posted
Study publicly available on registry
May 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2017
CompletedMay 24, 2017
June 1, 2015
1.3 years
May 12, 2014
May 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
52 weeks
Secondary Outcomes (1)
Time to Prostate Specific Antigen (PSA) Doubling Time
52 weeks
Study Arms (1)
DCVAC/PCa Arm
EXPERIMENTALDendritic Cells DCVAC/PCa Experimental therapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SOTIO a.s.lead
Study Sites (7)
Unknown Facility
Hradec Králové, Czechia
Unknown Facility
Jablonec nad Nisou, Czechia
Unknown Facility
Nový Jičín, Czechia
Unknown Facility
Olomouc, Czechia
Unknown Facility
Prague, Czechia
Unknown Facility
Uherské Hradiště, Czechia
Unknown Facility
Ústí nad Labem, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tomas Scheiner, PhD
Sotio Biotech Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2014
First Posted
May 14, 2014
Study Start
December 1, 2013
Primary Completion
April 1, 2015
Study Completion
March 20, 2017
Last Updated
May 24, 2017
Record last verified: 2015-06