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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

Phase 1
18 Years
75 Years
Not Enrolling
Neoplasms, Prostate, Prostate Cancer

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Trial Information

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

This Phase I/II study will be conducted according to a multicenter, open-label, single-group
design at approximately ten centers in Europe. At least 21 HSPC patients with rising PSA
after primary tumor treatment will be enrolled in this study. All patients will be treated
as out-patients and will receive the same treatment. The maximum dose will be 16
vaccinations. Follow-up: The patients' long-term safety and PSA status will be followed over
a period of 48 weeks. The Protocol Posting has been updated in order to comply with the FDA
Amendment Act, Sep 2007.

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Vaccine-related or possibly vaccine-related Grade 3 or 4 adverse event: a. Any Grade 4 toxicity: fatigue (including lethargy, asthenia, malaise) must have a duration of at least 24 hours. b. Any Grade 3 toxicity with a duration of at least 24 hours

Outcome Time Frame:

During the study

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Belgium: Ministry of Social Affairs, Public Health and the Environment

Study ID:




Start Date:

March 2005

Completion Date:

November 2006

Related Keywords:

  • Neoplasms, Prostate
  • Prostate Cancer
  • Neoplasms
  • Prostatic Neoplasms