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.