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Recurrent Prostate CancerPhase 1/2NCT02452307

Peptide-specific Vaccination in HLA-A*02 Positive Patients With Biochemical Recurrence After Radical Prostatectomy

A Phase 1/2 study testing Peptide vaccine, Montanide ISA-51 and Granulocyte macrophage colony stimulating factor (GM-CSF) in people with Recurrent Prostate Cancer, run by University Hospital Tuebingen.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study evaluates the prostate-specific antigen (PSA) response in HLA-A*02 positive patients with biochemical recurrence after radical prostatectomy treated with a prostate-specific peptide vaccine in combination with different immune-adjuvants. Read more about this study

Who is it for?
Ages 45 to 80 years, men only
Conditions the study is for
Recurrent Prostate Cancer
What is being tested?
Peptide vaccine, Montanide ISA-51 and Granulocyte macrophage colony stimulating factor (GM-CSF)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
Apr 2004to Oct 2017
Phase
Phase 1/2
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 45 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • biochemical recurrence after Radical Prostatectomy
  • no clinical metastases in CT or bone scan
  • HLA-Type: HLA-A*02 positive
  • Karnofsky-Performance-Index >70
  • Age >45 / <80 years
  • no prior or ongoing hormonal therapy
Show all 9Show fewer
  • no ongoing radiation therapy
  • Serum-Creatinine <2mg/dl; Bilirubin: <2gm/dl
  • no history of allergy or chronic obstructive lung disease (COLD)

Who cannot join

  • Patients unable to consent
  • Karnofsky-Performance-Index <70
  • known allergy or COLD
  • presence of secondary malignancy
  • prior or ongoing hormonal treatment
  • ongoing radiotherapy
  • immunosuppressive medication
  • seizure

About this study

Official title: Prospective Randomized Trial of Peptide-specific Vaccination in HLA-A*02 Positive Prostate Carcinoma Patients With Biochemical Recurrence After Radical Prostatectomy

The study evaluates the prostate-specific antigen (PSA) response in HLA-A*02 positive patients with biochemical recurrence after radical prostatectomy treated with a prostate-specific peptide vaccine in combination with different immune-adjuvants.

Read the detailed description

Patients with a biochemical recurrence after initial therapy can be included.

Being tested
Peptide vaccine, Montanide ISA-51, Granulocyte macrophage colony stimulating factor (GM-CSF), Imiquimod, mRNA
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Peptide vaccineBiological

    subcutaneous

  • Montanide ISA-51Drug

    subcutaneous

  • Granulocyte macrophage colony stimulating factor (GM-CSF)Drug

    intradermal

  • ImiquimodDrug

    epicutaneous

  • mRNADrug

    subcutaneous

  • ProtaminDrug

    subcutaneous

  • local hyperthermiaProcedure or surgery

Study groups in NCT02452307
Study groupRoleWhat they receive
Peptide vaccineExperimentalSubcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51
Receives: Biological: Peptide vaccine; Drug: Montanide ISA-51
Peptide vaccine + GM-CSFExperimentalSubcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Granulocyte macrophage colony stimulating factor (GM-CSF)
Receives: Biological: Peptide vaccine; Drug: Montanide ISA-51; Drug: Granulocyte macrophage colony stimulating factor (GM-CSF)
Peptide vaccine + local hyperthermiaExperimentalSubcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia
Receives: Biological: Peptide vaccine; Drug: Montanide ISA-51; Procedure: local hyperthermia
Peptide vaccine + ImiquimodExperimentalSubcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod
Receives: Biological: Peptide vaccine; Drug: Montanide ISA-51; Drug: Imiquimod
Peptide vaccine + mRNA/ProtaminExperimentalSubcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin
Receives: Biological: Peptide vaccine; Drug: Montanide ISA-51; Drug: mRNA; Drug: Protamin

What is being measured

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

  1. Change from Baseline in Immune Response at day 70

    Immune Response, as measured by the change of in vitro and in vivo T cell response from baseline at day 0 to day 70

    Measured: Days 0-70

Secondary outcomes (2)

  1. Tolerability

    Tolerability, as measured by number of Participants with Adverse Events

    Measured: Days 0-420

  2. Treatment response

    Treatment response, from date of randomization until the date of first documented progression as measured by PSA-value

    Measured: Months 0-60

Timeline

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

  1. First posted22 May 2015 (estimated)
  2. Study startApr 2004
  3. Primary completionOct 2017 (estimated)
  4. Study completionOct 2017 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02452307
Sponsor's protocol ID
167/2003
Status last verified
Aug 2017
First submitted
14 Apr 2015
Last updated
17 Aug 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Peptide vaccine, Montanide ISA-51 and Granulocyte macrophage colony stimulating factor (GM-CSF) in people with Recurrent Prostate Cancer, run by University Hospital Tuebingen.

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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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?

Change from Baseline in Immune Response at day 70 (time frame: Days 0-70). 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 NCT02452307.

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 17 Aug 2017.

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