Efficacy and Safety Study of the Therapeutic Vaccine PEP223 in Prostate Cancer Patients
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.
1 other identifier
interventional
12
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 prostate-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 6, 2009
CompletedFirst Posted
Study publicly available on registry
May 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedMay 8, 2009
May 1, 2009
1.2 years
May 6, 2009
May 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Testosterone suppression
after 12 weeks treatment as compared to baseline
Secondary Outcomes (5)
The time course of testosterone suppression
after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
Effects on LH and FSH levels
after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
Effects on PSA levels
after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
Antibody response to PEP223/CoVaccine HT
after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
Safety (adverse events, laboratory values, injection site reactions)
as applicable
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 radiotherapy for prostate cancer
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pepscan Therapeuticslead
- TFS Trial Form Supportcollaborator
Study Sites (2)
UMC Groningen
Groningen, 9713 GZ, Netherlands
UMC Nijmegen
Nijmegen, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 6, 2009
First Posted
May 8, 2009
Study Start
October 1, 2008
Primary Completion
December 1, 2009
Last Updated
May 8, 2009
Record last verified: 2009-05