Status:
UNKNOWN
Efficacy and Safety Study of the Therapeutic Vaccine PEP223 in Prostate Cancer Patients
Lead Sponsor:
Pepscan Therapeutics
Collaborating Sponsors:
TFS Trial Form Support
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE1
PHASE2
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 ...
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 growt...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00895466
Start Date
October 1 2008
Last Update
May 8 2009
Active Locations (2)
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1
UMC Groningen
Groningen, Netherlands, 9713 GZ
2
UMC Nijmegen
Nijmegen, Netherlands