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.