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

Inclusion criteria:

* Male,
* Aged between 18 and 75 years, inclusive,
* Histologically or cytologically proven adenocarcinoma of the prostate before the initiation of therapy of the primary tumor,
* Radical prostatectomy before progression of disease by rising PSA was established,
* Primary tumor presented a Gleason sum score ≤8,
* Proven progressive hormone-sensitive prostate cancer,
* Serum testosterone level above 50 ng/dl,
* Free of clinically evaluable metastatic disease (other than the rising PSA),
* ECOG Performance Status of 0 or 1,
* Normal organ functions,
* Negative HBV antigen test,
* Negative HCV antibody test,
* The investigator believes that the patient can and will comply with the requirements of the protocol,
* Written, informed consent obtained before enrolment.

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.