Efficacy and Safety Study of the Therapeutic Vaccine PEP223 in Prostate Cancer Patients
Recruitment status was: Recruiting
|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.|
- Testosterone suppression [ Time Frame: after 12 weeks treatment as compared to baseline ]
- 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 ]
|Study Start Date:||October 2008|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895466
|Groningen, Netherlands, 9713 GZ|