Prostate CancerPhase 2NCT02107430
Phase II Study of DCVAC/PCa After Primary Radiotherapy for Patients With High Risk Localized Prostate Cancer
A Phase 2 study testing Dendritic Cells DCVAC/PCa and Standard radiotherapy in people with Prostate Cancer, run by SOTIO a.s. at 6 sites in Czechia.
Trial summary
The purpose of this study is to determine whether DCVAC/PCa added after radical primary prostatectomy can improve PSA progression times within 5 years for patients with high risk 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 and Standard radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 6 sitesCzechia
- Study dates
- Mar 2012to Oct 2018
- 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 localized prostate cancer of high risk or very high risk fulfilling at least one of the following: T3-T4 stage or Gleason Score 8-10 or PSA level above 20 ng/ml
- Indication for prostate cancer radical radiotherapy
- Neo-adjuvant androgen androgen-deprivation therapy due to prostate cancer using Luteinizing-hormone-releasing hormone (LHRH) analogues ongoing for at least two months and not longer than 12 months prior randomization
- Eastern Cooperative Oncology Group (ECOG) 0-2
Who cannot join
- Primary surgical treatment of prostate cancer
- Prior or ongoing chemotherapy for prostate cancer
- Participation in other clinical study or administration of other evaluated drug within 30 day prior screening
- Unresolved lasting obstruction of urinary system
- Other uncontrolled inter-current illness
- Treatment with immunotherapy against Prostate Cancer
Show all 9Show fewer
- Clinically significant cardiovascular disease
- History of primary immunodeficiency
- Active autoimmune disease requiring treatment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Czechia6 sites
Nemocnice Jihlava,Urologické oddělení,
Jihlava, 586 33
Fakultní nemocnice Olomouc
Olomouc, 775 20
FN Ostrava, Onkologická klinika
Ostrava, 708 52
FNKV Klinika radiologie a onkologie
Prague, 100 34
FN Motol
Prague, 150 06
Nemocnice Na Bulovce
Prague, 180 00
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 Localized High-risk Prostate Cancer After Primary Radiotherapy
The purpose of this study is to determine whether DCVAC/PCa added after radical primary prostatectomy can improve PSA progression times within 5 years for patients with high risk localized Prostate Cancer.
Read the detailed description
Treatment post radical primary prostatectomy Treatment post standard radiotherapy
- Conditions
- Prostate Cancer
- Being tested
- Dendritic Cells DCVAC/PCa, Standard radiotherapy
- 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 arm post radiotherapy
Standard radiotherapyRadiation
radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| DCVAC/PCa arm post radiotherapy | Experimental | Dendritic Cells DCVAC/PCa Experimental therapy post radiotherapy Receives: Biological: Dendritic Cells DCVAC/PCa |
| Standard radiotherapy | Active comparator | Standard care Receives: Biological: Dendritic Cells DCVAC/PCa; Radiation: Standard radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Prostate Specific Antigen (PSA) failures in 5 years
PSA failure per Phoenix criteria of increase of 2ng/mL over nadir
Measured: Enrollment up to 260 weeks
Secondary outcomes (3)
Proportion of Patients without use of salvage therapy within 5 years
Calculation of the proportion of patients without use of salvage therapy within 5 years
Measured: Enrollment up to 260 weeks
Frequency of Adverse Events
Safety profile as defined by the nature, incidence, duration, severity and outcome of adverse events
Measured: enrollment up to 260 weeks
Proportion of Patients without Objective disease progression within 5 years
Proportion of patients who do not have a >2ng/mL elevation in PSA or require salvage therapy
Measured: Enrollment up to 260 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 completionSep 2013
- Study completionOct 2018
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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOTIO a.s.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomas Scheiner, Study director, Sotio Biotech Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107430
- Sponsor's protocol ID
- SP004
- Other IDs
- 2011-004967-65
- Status last verified
- Sep 2018
- First submitted
- 4 Apr 2014
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Clinical trial results will be reported as required by European legislation in clinicaltrialsregister.eu.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. 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 Localized High-risk Prostate Cancer After Primary Radiotherapy
- ClinicalTrials.gov ID
- NCT02107430
- Acronym / sponsor ID
- SP004
- Conditions
- Prostate Cancer
- Keywords
- Immunotherapy, Prostate Cancer, Biological, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- SOTIO a.s.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2018 (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 progression times within 5 years for patients with high risk localized Prostate Cancer.
Detailed description
Treatment post radical primary prostatectomy Treatment post standard radiotherapy
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 post radiotherapy | Experimental | Biological: Dendritic Cells DCVAC/PCaDendritic Cells DCVAC/PCa Experimental therapy post radiotherapy |
| Standard radiotherapy | Active comparator | Biological: Dendritic Cells DCVAC/PCa, Radiation: Standard radiotherapyStandard care |
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)
- Male 18 years and older
- Histologically confirmed localized prostate cancer of high risk or very high risk fulfilling at least one of the following: T3-T4 stage or Gleason Score 8-10 or PSA level above 20 ng/ml
- Indication for prostate cancer radical radiotherapy
- Neo-adjuvant androgen androgen-deprivation therapy due to prostate cancer using Luteinizing-hormone-releasing hormone (LHRH) analogues ongoing for at least two months and not longer than 12 months prior randomization
- Eastern Cooperative Oncology Group (ECOG) 0-2
Key exclusion criteria (9 listed)
- Primary surgical treatment of prostate cancer
- Prior or ongoing chemotherapy for prostate cancer
- Participation in other clinical study or administration of other evaluated drug within 30 day prior screening
- Unresolved lasting obstruction of urinary system
- Other uncontrolled inter-current illness
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 arm post radiotherapy | Biological | DCVAC/PCa arm post radiotherapy, Standard radiotherapy |
| Standard radiotherapyradiotherapy | Radiation | Standard radiotherapy |
Primary outcome
Number of Prostate Specific Antigen (PSA) failures in 5 years
Time frame: Enrollment up to 260 weeks
PSA failure per Phoenix criteria of increase of 2ng/mL over nadir
3 secondary outcomes
Proportion of Patients without use of salvage therapy within 5 years
Time frame: Enrollment up to 260 weeks
Frequency of Adverse Events
Time frame: enrollment up to 260 weeks
Proportion of Patients without Objective disease progression within 5 years
Time frame: Enrollment up to 260 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 14 Nov 2018.
- Individual participant dataSharing planned: Yes. Clinical trial results will be reported as required by European legislation in clinicaltrialsregister.eu.
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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 study director
Sotio Biotech Inc.
6 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 Standard radiotherapy in people with Prostate Cancer, run by SOTIO a.s. at 6 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 9 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Number of Prostate Specific Antigen (PSA) failures in 5 years (time frame: Enrollment up to 260 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 14 Nov 2018.