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

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