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Neoplasms, ProstatePhase 1NCT00148928

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

A Phase 1 study testing P501-AS15 vaccine in people with Neoplasms, Prostate, run by GlaxoSmithKline at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with hormone-sensitive prostate cancer and rising PSA, after primary tumor treatment, will be treated with the P501-AS15 vaccine as out-patients. The maximum dose will be 16 vaccinations, given over a period of approximately one year. Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Neoplasms, Prostate
What is being tested?
P501-AS15 vaccine
Type of treatment
Vaccines
How many people
25 participants
Where
8 sitesin 2 countries
Study dates
1 Mar 2005to 7 Nov 2006
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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.

Who cannot join

  • 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,
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  • 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.

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

France5 sites

  • GSK Investigational Site

    Auxerre, 89011

  • GSK Investigational Site

    Besançon, 25030

  • GSK Investigational Site

    Paris, 75248

  • GSK Investigational Site

    Toulouse, 31403

  • GSK Investigational Site

    Villejuif, 94805

Other trials in France

Belgium3 sites

  • GSK Investigational Site

    Brussels, 1070

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Turnhout, 2300

Other trials in Belgium

About this study

Official title: 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

Patients with hormone-sensitive prostate cancer and rising PSA, after primary tumor treatment, will be treated with the P501-AS15 vaccine as out-patients. The maximum dose will be 16 vaccinations, given over a period of approximately one year. Thereafter, the patients' long-term safety and PSA status will be followed over a period of approximately 11 months.

Read the detailed description

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.

Being tested
P501-AS15 vaccine
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P501-AS15 vaccineBiological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: During the study

  2. Clinical PSA response

Secondary outcomes (6)

  1. a. For patients who present a PSA response: The duration of PSA response, The duration of PSA control, The duration of log PSA response.

    Measured: During the study

  2. b. Humoral immune response induced by P501-AS15 vaccine: Anti-CPC seropositivity. Anti-P501 seropositivity.

    Measured: At all points during treatment as specified in the study schedule

  3. c. Cellular immune response induced by P501-AS15 vaccine. Frequency of in vitro cellular immune response to CPC P501.

    Measured: At all points during treatment as specified in the study schedule

  4. d. Any toxicity in terms of solicited symptoms, unsolicited symptoms and serious adverse events.

    Measured: During the study

  5. e. All adverse events, whether or not associated with toxicity.

    Measured: During the study

  6. f. General laboratory safety variables.

    Measured: At all points during treatment as specified in the study schedule

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2005 (estimated)
  2. Study start1 Mar 2005
  3. Primary completion7 Nov 2006
  4. Study completion7 Nov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00148928
Sponsor's protocol ID
102238
Other IDs
104634
Status last verified
Jun 2017
First submitted
7 Sep 2005
Last updated
2 Jun 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing P501-AS15 vaccine in people with Neoplasms, Prostate, run by GlaxoSmithKline at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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 (time frame: During the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00148928.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.

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