A Multicenter, Open-label Phase I/II Trial to Evaluate the Safety and Activity of CPC-P501 Protein Formulated With the Adjuvant AS15 as First-line Treatment in Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSA

Inclusion Criteria

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.