Prostate CancerPhase 2NCT02105675
Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
A Phase 2 study testing Dendritic Cells DCVAC/PCa and Docetaxel in people with Prostate Cancer and Prostate Cancer Metastatic, run by SOTIO a.s. at 10 sites in Czechia.
Trial summary
The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care therapy can improve survival times for patients with Metastatic Castration Resistant 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, Prostate Cancer Metastatic
- What is being tested?
- Dendritic Cells DCVAC/PCa and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesCzechia
- Study dates
- Feb 2012to 20 Feb 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
- Men aged ≥ 18 years
- Histologically confirmed prostate cancer
- Presence of skeletal metastasis (by CT or PET or MRI)
- Disease progression documented by increasing PSA or two new lesions
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
Who cannot join
- Confirmed brain and/or leptomeningeal metastases
- Prior chemotherapy 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Czechia10 sites
Study site
Brno
Study site
Hradec Králové
Study site
Jihlava
Study site
Liberec
Study site
Nová Ves pod Pleší
Study site
Olomouc
Study site
Ostrava
Study site
Prague
Study site
Ústí nad Labem
Study site
Zlín
About this study
Official title: Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Castrate-resistant Prostate Cancer
The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care therapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic
- Being tested
- Dendritic Cells DCVAC/PCa, Docetaxel
- Keywords
- Immunotherapy, Metastatic, Castrate Resistant, Prostate Cancer, Biological, Vaccine
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
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 is the experimental therapy added on to Docetaxel
DocetaxelDrug
Also called taxotere
Docetaxel is Standard of Care First Line Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| DCVAC/PCa add on to Standard of Care | Experimental | Combination therapy with Dendritic Cells DCVAC/PCa and Standard of Care Receives: Biological: Dendritic Cells DCVAC/PCa |
| Standard of Care | Active comparator | Docetaxel as an Active Comparator Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Measured: 135 weeks
Secondary outcomes (5)
Radiographic Progression Free Survival
Measured: 135 weeks
Duration to Prostate Specific Antigen (PSA) Progression
Measured: 135 weeks
Changes in Quality of Life (QOL) assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Measured: 0, 10, 22, 37, 53, 65 weeks
Changes in Pain assessed by EORTC QLQ-C30
Measured: 0, 10, 22, 37, 53, 65 weeks
Incidence of Adverse Events
Measured: 135 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startFeb 2012
- Primary completionMar 2014
- Study completion20 Feb 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
- 60 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 Biotech Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105675
- Sponsor's protocol ID
- SP001
- Other IDs
- 2011-004735-32
- Status last verified
- Jun 2015
- First submitted
- 24 Mar 2014
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: possibly shared on EMA website
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 of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Castrate-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT02105675
- Acronym / sponsor ID
- SP001
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic
- Keywords
- Immunotherapy, Metastatic, Castrate Resistant, Prostate Cancer, Biological, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SOTIO a.s.Industry (pharma, biotech, devices)
- Study start
- Feb 2012 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- 20 Feb 2017 (actual)
- First posted
- 7 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 onto Standard of Care therapy can improve survival times for patients with Metastatic Castration Resistant 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 add on to Standard of Care | Experimental | Biological: Dendritic Cells DCVAC/PCaCombination therapy with Dendritic Cells DCVAC/PCa and Standard of Care |
| Standard of Care | Active comparator | Drug: DocetaxelDocetaxel as an Active Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men aged ≥ 18 years
- Histologically confirmed prostate cancer
- Presence of skeletal metastasis (by CT or PET or MRI)
- Disease progression documented by increasing PSA or two new lesions
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
Key exclusion criteria (7 listed)
- Confirmed brain and/or leptomeningeal metastases
- Prior chemotherapy for prostate cancer
- Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
- Other uncontrolled intercurrent illness
- Treatment with immunotherapy against PCa
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 is the experimental therapy added on to Docetaxel | Biological | DCVAC/PCa add on to Standard of Care |
| DocetaxelAlso: taxotereDocetaxel is Standard of Care First Line Chemotherapy | Drug | Standard of Care |
Primary outcome
Survival rate
Time frame: 135 weeks
5 secondary outcomes
Radiographic Progression Free Survival
Time frame: 135 weeks
Duration to Prostate Specific Antigen (PSA) Progression
Time frame: 135 weeks
Changes in Quality of Life (QOL) assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Time frame: 0, 10, 22, 37, 53, 65 weeks
Changes in Pain assessed by EORTC QLQ-C30
Time frame: 0, 10, 22, 37, 53, 65 weeks
Incidence of Adverse Events
Time frame: 135 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.
- Individual participant dataSharing planned: Undecided. possibly shared on EMA website
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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 Biotech Inc.
10 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 and Docetaxel in people with Prostate Cancer and Prostate Cancer Metastatic, run by SOTIO a.s. at 10 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 5 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 10 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?
Survival rate (time frame: 135 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.