Prostate CancerPhase 2NCT02107391
Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate Cancer
A Phase 2 study testing Dendritic Cells DCVAC/PCa, Leuprolide acetate and Goserelin Acetate in people with Prostate Cancer, run by SOTIO a.s. at 9 sites in Czechia.
Trial summary
The purpose of this study is to determine whether DCVAC/PCa added onto hormone therapy can improve PSA progression times for patients with Metastatic 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, Leuprolide acetate and Goserelin Acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 9 sitesCzechia
- Study dates
- Mar 2012to Jun 2016
- 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 prostate adenocarcinoma
- Presence of bone or soft tissue metastasis (by CT or PET or MRI and/or scintigraphy)
- Androgen deprivation therapy using Luteinizing-hormone-releasing hormone ( LHRH) analogues commenced at least one month and at most three months prior randomization or orchiectomy performed at least one month and at most three months prior randomization
- Serum testosterone level at screening (≤ 1.7 nmol/l, resp. ≤ 50 ng/dL)
- Eastern Cooperative Oncology Group (ECOG) 0-2
Who cannot join
- Confirmed brain and/or leptomeningeal metastases
- Prior or ongoing chemotherapy 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
9 sites in 1 country.
9 sites in 1 country
Czechia9 sites
Study site
Jablonec nad Nisou
Study site
Jihlava
Study site
Liberec
Study site
Mníšek pod Brdy
Study site
Olomouc
Study site
Pilsen
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 Combination With Hormone Therapy in Patients With Metastatic Prostate Cancer
The purpose of this study is to determine whether DCVAC/PCa added onto hormone therapy can improve PSA progression times for patients with Metastatic Prostate Cancer.
Read the detailed description
Use of vaccine to improve Prostate Specific Antigen (PSA) levels.
- Conditions
- Prostate Cancer
- Being tested
- Dendritic Cells DCVAC/PCa, Leuprolide acetate, Goserelin Acetate
- Keywords
- Immunotherapy, Prostate Cancer, Biological, Vaccine, Androgen Deprivation Therapy
- 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
Combination therapy with DCVAC/PCA add on to and Standard of Care Hormone Therapy
Leuprolide acetateDrug
Also called Lupron
Standard of Care Hormone Therapy as an Active Comparator
Goserelin AcetateDrug
Also called Zoladex
Standard of Care Hormone Therapy as an Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| DCVAC/PCA added Standard Hormone Therapy | Experimental | Combination therapy with Dendritic Cells DCVAC/PCa added on to a Standard of Care Hormone Therapy Receives: Biological: Dendritic Cells DCVAC/PCa |
| Standard of Care Hormone Therapy | Active comparator | Standard of Care Hormone Therapy as an Active Comparator Goserelin Acetate Leuprolide Acetate Receives: Drug: Leuprolide acetate; Drug: Goserelin Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with PSA Progression
Measured: 104 weeks
Secondary outcomes (5)
Proportion of patients with Progression of Disease
Measured: 0, 6, 16, 28, 40, 52, 65, 78, 91, 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
Frequency of Skeletal Related Events
Measured: 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks
Changes in Quality of Life (QOL) assessed by EORTC QLQ-C30
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30
Measured: 0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks
Changes in Pain assessed by EORTC QLQ-C30
Pain Scale from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30
Measured: 0, 16, 28, 40, 52, 52, 65, 78, 91, 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 startMar 2012
- Primary completionDec 2015
- Study completionJun 2016
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
- 63 participants (actual)
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
- NCT02107391
- Sponsor's protocol ID
- SP002
- Other IDs
- 2011-004986-34
- 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 of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Combination With Hormone Therapy in Patients With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT02107391
- Acronym / sponsor ID
- SP002
- Conditions
- Prostate Cancer
- Keywords
- Immunotherapy, Prostate Cancer, Biological, Vaccine, Androgen Deprivation Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- SOTIO a.s.Industry (pharma, biotech, devices)
- Study start
- Mar 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (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 onto hormone therapy can improve PSA progression times for patients with Metastatic Prostate Cancer.
Detailed description
Use of vaccine to improve Prostate Specific Antigen (PSA) levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCVAC/PCA added Standard Hormone Therapy | Experimental | Biological: Dendritic Cells DCVAC/PCaCombination therapy with Dendritic Cells DCVAC/PCa added on to a Standard of Care Hormone Therapy |
| Standard of Care Hormone Therapy | Active comparator | Drug: Leuprolide acetate, Drug: Goserelin AcetateStandard of Care Hormone Therapy as an Active Comparator Goserelin Acetate Leuprolide Acetate |
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 prostate adenocarcinoma
- Presence of bone or soft tissue metastasis (by CT or PET or MRI and/or scintigraphy)
- Androgen deprivation therapy using Luteinizing-hormone-releasing hormone ( LHRH) analogues commenced at least one month and at most three months prior randomization or orchiectomy performed at least one month and at most three months prior randomization
- Serum testosterone level at screening (≤ 1.7 nmol/l, resp. ≤ 50 ng/dL)
Key exclusion criteria (7 listed)
- Confirmed brain and/or leptomeningeal metastases
- Prior or ongoing chemotherapy 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/PCaCombination therapy with DCVAC/PCA add on to and Standard of Care Hormone Therapy | Biological | DCVAC/PCA added Standard Hormone Therapy |
| Leuprolide acetateAlso: LupronStandard of Care Hormone Therapy as an Active Comparator | Drug | Standard of Care Hormone Therapy |
| Goserelin AcetateAlso: ZoladexStandard of Care Hormone Therapy as an Active Comparator | Drug | Standard of Care Hormone Therapy |
Primary outcome
Proportion of patients with PSA Progression
Time frame: 104 weeks
5 secondary outcomes
Proportion of patients with Progression of Disease
Time frame: 0, 6, 16, 28, 40, 52, 65, 78, 91, 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
Frequency of Skeletal Related Events
Time frame: 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks
Changes in Quality of Life (QOL) assessed by EORTC QLQ-C30
Time frame: 0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks
Changes in Pain assessed by EORTC QLQ-C30
Time frame: 0, 16, 28, 40, 52, 52, 65, 78, 91, 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
9 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, Leuprolide acetate and Goserelin Acetate in people with Prostate Cancer, run by SOTIO a.s. at 9 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 9 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?
Proportion of patients with PSA Progression (time frame: 104 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.