Safety & Activity of P501-AS15 Vaccine as a First-line Treatment for Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSA

Exclusion Criteria

• •Orchiectomy,
• •Received androgen-deprivation therapy, including neo adjuvant androgen-deprivation therapy,
• •Any radiotherapy (external beam radiotherapy and/or brachytherapy) for prostate cancer as primary management,
• •Receiving treatment with continuous systemic anticancer medications,
• •Received chronic administration of immunosuppressants or other immune-modifying drugs within six months before the first vaccine dose,
• •Received any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or the administration of such a product is planned during the study period,
• •Receiving any immunoglobulins and/or other blood products or has received such products within the three months preceding the first dose of study vaccine or is planned to receive such products during the study period,
• •Received any commercial vaccine within the week before the first study vaccination,
• •Previous or concomitant malignancies at other sites, except (i) adequately treated non-melanoma skin cancers, and (ii) effectively treated malignancy that has been in remission for \>2 years and is considered by the investigator highly likely to have been cured,
• •Any clinical autoimmune disease (except vitiligo),
• •Family history of congenital or hereditary immunodeficiency,
• •HIV-positive,
• •Medical history includes splenectomy or irradiation to the spleen,
• •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine,
• •Any known allergy or hypersensitivity to yeast or yeast products,
• •The patient presents with serious acute or chronic illness(es), e.g. active infections requiring antibiotics, bleeding/coagulation disorders, clinically significant heart disease (NCIC CTG III-IV), or other conditions requiring concurrent medications not allowed during this study,
• •Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule,
• •History of chronic alcohol consumption and/or drug abuse,
• •Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness.