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.
N/A
N/A
Male
Prostate Cancer
Trial Information
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
N/A
Outcome Measure:
Testosterone suppression
Outcome Time Frame:
after 12 weeks treatment as compared to baseline
Safety Issue:
No
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
PEP223-NL-0701
NCT ID:
NCT00895466
Start Date:
October 2008
Completion Date:
Related Keywords:
- Prostate Cancer
- prostatic diseases
- neoplasms
- prostatic neoplasms
- hormones
- androgen antagonists
- vaccines
- peptide vaccines
- adjuvants, immunological
- Prostatic Neoplasms
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