Prostate CancerPhase 1/2NCT00895466
Efficacy and Safety Study of the Therapeutic Vaccine PEP223 in Prostate Cancer Patients
A Phase 1/2 study testing PEP-223/CoVaccine HT in people with Prostate Cancer, run by Pepscan Therapeutics at 2 sites in Netherlands.
Trial summary
The purpose of this trial is to investigate whether treatment with this new drug will result in lower testosterone levels in men with prostate cancer. At the same time it will be investigated whether the drug induces side effects, and if so, which ones. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PEP-223/CoVaccine HT
- Type of treatment
- Vaccines
- How many people
- 12 participants
- Where
- 2 sitesNetherlands
- Study dates
- Oct 2008to Dec 2009
- Phase
- Phase 1/2
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- pathological confirmed prostatic adenocarcinoma, clinical stage (c) cT1-3, cN0-1/x, cM0
- baseline testosterone levels of > 4 nmol/l
- baseline PSA level of > 10 microg/l
- eligible for hormone therapy
- willingness to comply with the protocol conditions and procedures
- willing and able to give informed consent
Who cannot join
- clinical evidence of distant metastases
- previous hormonal therapy administered specifically for prostatic carcinoma
- development of another invasive neoplastic disease during the previous 5 years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin
- primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications
- concomitant administration - or administration during the 12 weeks preceding study inclusion - of immune enhancing medication or testosterone supplements
- concomitant radiotherapy for prostate cancer
Show all 10Show fewer
- presence of bacterial prostatitis causing a PSA increase during the 8 weeks preceding study inclusion
- simultaneous participation in another clinical trial or participation in a clinical trial involving investigational drugs within 3 months before enrollment into the present study
- BMI > 30 kg/square meter
- previous serious reaction to a vaccine such as angioedema or anaphylaxis
Trial locations and contacts
2 sites in 1 country.
Drug Development contact
Netherlands2 sites, 2 recruiting
- Recruiting
UMC Groningen
Groningen, 9713 GZ
- Recruiting
UMC Nijmegen
Nijmegen
About this study
Official title: A Phase I-II Open Label Clinical Trial, Evaluating the Efficacy and Safety of Administration of the Therapeutic Vaccine PEP-223/CoVaccine HT, to Hormone Treatment naïve, Immunocompetent Subjects With T1-3, N0-1/x, M0 Prostate Cancer, Eligible for Hormone Therapy.
The purpose of this trial is to investigate whether treatment with this new drug will result in lower testosterone levels in men with prostate cancer. At the same time it will be investigated whether the drug induces side effects, and if so, which ones.
Read the detailed description
Prostate cancer growth is influenced by the male hormone testosterone. Treatment with drugs that stop the production of testosterone often results in a decrease of the tumor or inhibition of its growth. This is particularly important prior to radiotherapy, since radiation can better be focused on the prostate with as a result less frequent or less severe side effects of the radiation.
Most of the drugs used to date to stop the production of testosterone have the disadvantage that initially they may cause a rise of testosterone levels before the production is effectively blocked. The new drug that will be investigated in this trial is a vaccine. The vaccine offers a different treatment modality since it interferes at a different level of the hormonal axis that drives the testosterone production; it will not cause an initial surge.
In this trial the vaccine will be administered three times, testosterone levels will be monitored for a total period of three months.
- Conditions
- Prostate Cancer
- Being tested
- PEP-223/CoVaccine HT
- Keywords
- prostatic diseases, neoplasms, prostatic neoplasms, hormones, androgen antagonists, vaccines, peptide vaccines, adjuvants, immunological
- Medical subject headings
- Prostatic Neoplasms, Prostatic Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP-223/CoVaccine HTBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosterone suppression
Measured: after 12 weeks treatment as compared to baseline
Secondary outcomes (5)
The time course of testosterone suppression
Measured: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
Effects on LH and FSH levels
Measured: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
Effects on PSA levels
Measured: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
Antibody response to PEP223/CoVaccine HT
Measured: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
Safety (adverse events, laboratory values, injection site reactions)
Measured: as applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2009
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 1/2
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pepscan Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895466
- Sponsor's protocol ID
- PEP223-NL-0701
- Status last verified
- May 2009
- First submitted
- 6 May 2009
- Last updated
- 8 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Open Label Clinical Trial, Evaluating the Efficacy and Safety of Administration of the Therapeutic Vaccine PEP-223/CoVaccine HT, to Hormone Treatment naïve, Immunocompetent Subjects With T1-3, N0-1/x, M0 Prostate Cancer, Eligible for Hormone Therapy.
- ClinicalTrials.gov ID
- NCT00895466
- Acronym / sponsor ID
- PEP223-NL-0701
- Conditions
- Prostate Cancer
- Keywords
- prostatic diseases, neoplasms, prostatic neoplasms, hormones, androgen antagonists, vaccines, peptide vaccines, adjuvants, immunological
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Pepscan TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support
- Study start
- Oct 2008
- Primary completion
- Dec 2009
- First posted
- 8 May 2009 (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 trial is to investigate whether treatment with this new drug will result in lower testosterone levels in men with prostate cancer. At the same time it will be investigated whether the drug induces side effects, and if so, which ones.
Detailed description
Prostate cancer growth is influenced by the male hormone testosterone. Treatment with drugs that stop the production of testosterone often results in a decrease of the tumor or inhibition of its growth. This is particularly important prior to radiotherapy, since radiation can better be focused on the prostate with as a result less frequent or less severe side effects of the radiation.
Most of the drugs used to date to stop the production of testosterone have the disadvantage that initially they may cause a rise of testosterone levels before the production is effectively blocked. The new drug that will be investigated in this trial is a vaccine. The vaccine offers a different treatment modality since it interferes at a different level of the hormonal axis that drives the testosterone production; it will not cause an initial surge.
In this trial the vaccine will be administered three times, testosterone levels will be monitored for a total period of three months.
Study design
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- pathological confirmed prostatic adenocarcinoma, clinical stage (c) cT1-3, cN0-1/x, cM0
- baseline testosterone levels of > 4 nmol/l
- baseline PSA level of > 10 microg/l
- eligible for hormone therapy
- willingness to comply with the protocol conditions and procedures
Key exclusion criteria (10 listed)
- clinical evidence of distant metastases
- previous hormonal therapy administered specifically for prostatic carcinoma
- development of another invasive neoplastic disease during the previous 5 years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin
- primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications
- concomitant administration - or administration during the 12 weeks preceding study inclusion - of immune enhancing medication or testosterone supplements
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 |
|---|---|---|
| PEP-223/CoVaccine HT | Biological | – |
Primary outcome
Testosterone suppression
Time frame: after 12 weeks treatment as compared to baseline
5 secondary outcomes
The time course of testosterone suppression
Time frame: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
Effects on LH and FSH levels
Time frame: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
Effects on PSA levels
Time frame: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
Antibody response to PEP223/CoVaccine HT
Time frame: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
Safety (adverse events, laboratory values, injection site reactions)
Time frame: as applicable
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2009.
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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.
Drug Development contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PEP-223/CoVaccine HT in people with Prostate Cancer, run by Pepscan Therapeutics at 2 sites in Netherlands.
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 10 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: status not confirmed, as of the sponsor's last update on 8 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Drug Development (info@pepscan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testosterone suppression (time frame: after 12 weeks treatment as compared to baseline). 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 8 May 2009.