Study to Allow for Second Treatment Cycle of DCVAC in Patients With Localized Prostate Cancer
Phase 2
Completed
- Conditions
- Prostate Cancer
- Interventions
- Biological: Dendritic Cells DCVAC/PCa
- Registration Number
- NCT02137746
- Lead Sponsor
- SOTIO a.s.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DCVAC/PCa Arm Dendritic Cells DCVAC/PCa Dendritic Cells DCVAC/PCa Experimental therapy
- Primary Outcome Measures
Name Time Method Safety evaluation of the second cycle of DCVAC 52 weeks 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
Name Time Method Time to Prostate Specific Antigen (PSA) Doubling Time 52 weeks