Efficacy and Safety Study of the Therapeutic Vaccine PEP223 in Prostate Cancer Patients

Prostate Cancer Clinical Trial

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.

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 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. ;

Study Design

N/A

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00895466
• Study type: Interventional
• Source: Pepscan Therapeutics
• Contact: Drug Development
• Email: info@pepscan.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 2008