Prostate CancerPhase 2NCT02107404
Phase II Study of DCVAC/PCa Added After Radical Primary Prostatectomy for Patients With Localized Prostate Cancer
A Phase 2 study testing Dendritic Cells DCVAC/PCa in people with Prostate Cancer, run by SOTIO a.s. at 11 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Dendritic Cells DCVAC/PCa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 11 sitesCzechia
- Study dates
- Apr 2012to 22 May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Czechia11 sites
Study site
Brno
Study site
Hradec Králové
Study site
Jablonec nad Nisou
Study site
Jihlava
Study site
Mníšek pod Brdy
Study site
Nový Jičín
Study site
Olomouc
Study site
Pilsen
Study site
Prague
Study site
Uherské Hradiště
Study site
Ústí nad Labem
About this study
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
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.
- Conditions
- Prostate Cancer
- Being tested
- Dendritic Cells DCVAC/PCa
- Keywords
- Immunotherapy, Prostate Cancer, Biological, Vaccine
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendritic Cells DCVAC/PCaBiological
DCVAC/PCa Experimental therapy
| Study group | Role | What they receive |
|---|---|---|
| DCVAC/PCa Arm | Experimental | Dendritic Cells DCVAC/PCA Experimental therapy Receives: Biological: Dendritic Cells DCVAC/PCa |
| Standard Therapy | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40
Measured: 40 Weeks
Secondary outcomes (8)
Change in PSA Doubling Time during Follow-up from week 40 to 2 years after randomization
Measured: 104 Weeks
Frequency of Adverse Events
Measured: 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks
Proportion of Patients with Objective disease progression within 2 years
Measured: 104 Weeks
Number of Patients requiring further therapy at 2 years
Measured: 104 Weeks
Comparison of PSA Doubling Time in Treatment Phase with Immunotherapy with the Value Prior to Randomization
Measured: 104 Weeks
Proportion of patients after RPE with biochemical relapse within 2 years of randomization
Measured: 104 Weeks
Proportion of patients with progressive increase in PSA within 2 years of randomization
Measured: 104 Weeks
Overall survival
Measured: 104 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startApr 2012
- Primary completionJun 2015
- Study completion22 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SOTIO a.s.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomas Scheiner, PhD, Study director, Sotio Accord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107404
- Sponsor's protocol ID
- SP003
- Status last verified
- Jun 2015
- First submitted
- 4 Apr 2014
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02107404
- Acronym / sponsor ID
- SP003
- Conditions
- Prostate Cancer
- Keywords
- Immunotherapy, Prostate Cancer, Biological, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- SOTIO a.s.Industry (pharma, biotech, devices)
- Study start
- Apr 2012 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCVAC/PCa Arm | Experimental | Biological: Dendritic Cells DCVAC/PCaDendritic Cells DCVAC/PCA Experimental therapy |
| Standard Therapy | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dendritic Cells DCVAC/PCaDCVAC/PCa Experimental therapy | Biological | DCVAC/PCa Arm |
Primary outcome
Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40
Time frame: 40 Weeks
8 secondary outcomes
Change in PSA Doubling Time during Follow-up from week 40 to 2 years after randomization
Time frame: 104 Weeks
Frequency of Adverse Events
Time frame: 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks
Proportion of Patients with Objective disease progression within 2 years
Time frame: 104 Weeks
Number of Patients requiring further therapy at 2 years
Time frame: 104 Weeks
Comparison of PSA Doubling Time in Treatment Phase with Immunotherapy with the Value Prior to Randomization
Time frame: 104 Weeks
Proportion of patients after RPE with biochemical relapse within 2 years of randomization
Time frame: 104 Weeks
Proportion of patients with progressive increase in PSA within 2 years of randomization
Time frame: 104 Weeks
Overall survival
Time frame: 104 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomas Scheiner, PhD study director
Sotio Accord
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dendritic Cells DCVAC/PCa in people with Prostate Cancer, run by SOTIO a.s. at 11 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40 (time frame: 40 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.