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
In this trial the vaccine will be administered three times, testosterone levels will be
monitored for a total period of three months.
after 12 weeks treatment as compared to baseline
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)