Back to resultsPhase II Study of DCVAC/PCa Added After Radical Primary Prostatectomy for 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 Immunotherapy, Prostate Cancer, Biological, Vaccine
Eligibility Criteria
Inclusion Criteria:
- Male 18 years and older
- Histologically confirmed pT2 prostate cancer
- Post radical prostatectomy
- PSA values measured after the value greater than 0.020 ng/mL resulted in PSA doubling time (PSADT) equal or less than 12 months
- Salvage radiotherapy naïve with PSA increase within 2 years or after salvage radiotherapy with PSA not higher than 1 ng/ml
- Eastern Cooperative Oncology Group (ECOG) 0-2
Exclusion Criteria:
- Confirmed brain and/or leptomeningeal metastases
- Prior androgen deprivation therapy or orchiectomy for prostate cancer
- Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
- Other uncontrolled intercurrent illness
- Treatment with immunotherapy against prostate cancer
- Clinically significant cardiovascular disease
- Active autoimmune disease requiring treatment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
DCVAC/PCa Arm
Standard Therapy
Arm Description
Dendritic Cells DCVAC/PCA Experimental therapy
No Intervention
Outcomes
Primary Outcome Measures
Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40
Secondary Outcome Measures
Change in PSA Doubling Time during Follow-up from week 40 to 2 years after randomization
Frequency of Adverse Events
Proportion of Patients with Objective disease progression within 2 years
Number of Patients requiring further therapy at 2 years
Comparison of PSA Doubling Time in Treatment Phase with Immunotherapy with the Value Prior to Randomization
Proportion of patients after RPE with biochemical relapse within 2 years of randomization
Proportion of patients with progressive increase in PSA within 2 years of randomization
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02107404
Brief Title
Phase II Study of DCVAC/PCa Added After Radical Primary Prostatectomy for Patients With Localized Prostate Cancer
Official Title
Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial With Active Cellular Immunotherapy DCVAC/PCa in Patients With Localized Prostate Cancer After Primary Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
May 22, 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 after radical primary prostatectomy can improve PSA doubling times for patients with localized Prostate Cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Immunotherapy, 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
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DCVAC/PCa Arm
Arm Type
Experimental
Arm Description
Dendritic Cells DCVAC/PCA Experimental therapy
Arm Title
Standard Therapy
Arm Type
No Intervention
Arm Description
No Intervention
Intervention Type
Biological
Intervention Name(s)
Dendritic Cells DCVAC/PCa
Intervention Description
DCVAC/PCa Experimental therapy
Primary Outcome Measure Information:
Title
Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40
Time Frame
40 Weeks
Secondary Outcome Measure Information:
Title
Change in PSA Doubling Time during Follow-up from week 40 to 2 years after randomization
Time Frame
104 Weeks
Title
Frequency of Adverse Events
Time Frame
0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks
Title
Proportion of Patients with Objective disease progression within 2 years
Time Frame
104 Weeks
Title
Number of Patients requiring further therapy at 2 years
Time Frame
104 Weeks
Title
Comparison of PSA Doubling Time in Treatment Phase with Immunotherapy with the Value Prior to Randomization
Time Frame
104 Weeks
Title
Proportion of patients after RPE with biochemical relapse within 2 years of randomization
Time Frame
104 Weeks
Title
Proportion of patients with progressive increase in PSA within 2 years of randomization
Time Frame
104 Weeks
Title
Overall survival
Time Frame
104 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 pT2 prostate cancer
Post radical prostatectomy
PSA values measured after the value greater than 0.020 ng/mL resulted in PSA doubling time (PSADT) equal or less than 12 months
Salvage radiotherapy naïve with PSA increase within 2 years or after salvage radiotherapy with PSA not higher than 1 ng/ml
Eastern Cooperative Oncology Group (ECOG) 0-2
Exclusion Criteria:
Confirmed brain and/or leptomeningeal metastases
Prior androgen deprivation therapy or orchiectomy for prostate cancer
Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
Other uncontrolled intercurrent illness
Treatment with immunotherapy against prostate cancer
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 Accord
Official's Role
Study Director
Facility Information:
City
Brno
Country
Czechia
City
Hradec Kralove
Country
Czechia
City
Jablonec nad Nisou
Country
Czechia
City
Jihlava
Country
Czechia
City
Mnisek pod Brdy
Country
Czechia
City
Novy Jicin
Country
Czechia
City
Olomouc
Country
Czechia
City
Plzen
Country
Czechia
City
Praha 10
Country
Czechia
City
Praha 4
Country
Czechia
City
Praha 5
Country
Czechia
City
Uherske Hradiste
Country
Czechia
City
Usti nad Labem
Country
Czechia
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of DCVAC/PCa Added After Radical Primary Prostatectomy for Patients With Localized Prostate Cancer
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