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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Recurrent Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peptide vaccine

Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51

Group Type EXPERIMENTAL

Peptide vaccine

Intervention Type BIOLOGICAL

subcutaneous

Montanide ISA-51

Intervention Type DRUG

subcutaneous

Peptide vaccine + GM-CSF

Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Granulocyte macrophage colony stimulating factor (GM-CSF)

Group Type EXPERIMENTAL

Peptide vaccine

Intervention Type BIOLOGICAL

subcutaneous

Montanide ISA-51

Intervention Type DRUG

subcutaneous

Granulocyte macrophage colony stimulating factor (GM-CSF)

Intervention Type DRUG

intradermal

Peptide vaccine + local hyperthermia

Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia

Group Type EXPERIMENTAL

Peptide vaccine

Intervention Type BIOLOGICAL

subcutaneous

Montanide ISA-51

Intervention Type DRUG

subcutaneous

local hyperthermia

Intervention Type PROCEDURE

Peptide vaccine + Imiquimod

Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod

Group Type EXPERIMENTAL

Peptide vaccine

Intervention Type BIOLOGICAL

subcutaneous

Montanide ISA-51

Intervention Type DRUG

subcutaneous

Imiquimod

Intervention Type DRUG

epicutaneous

Peptide vaccine + mRNA/Protamin

Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin

Group Type EXPERIMENTAL

Peptide vaccine

Intervention Type BIOLOGICAL

subcutaneous

Montanide ISA-51

Intervention Type DRUG

subcutaneous

mRNA

Intervention Type DRUG

subcutaneous

Protamin

Intervention Type DRUG

subcutaneous

Interventions

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Peptide vaccine

subcutaneous

Intervention Type BIOLOGICAL

Montanide ISA-51

subcutaneous

Intervention Type DRUG

Granulocyte macrophage colony stimulating factor (GM-CSF)

intradermal

Intervention Type DRUG

Imiquimod

epicutaneous

Intervention Type DRUG

mRNA

subcutaneous

Intervention Type DRUG

Protamin

subcutaneous

Intervention Type DRUG

local hyperthermia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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
* no ongoing radiation therapy
* Serum-Creatinine \<2mg/dl; Bilirubin: \<2gm/dl
* no history of allergy or chronic obstructive lung disease (COLD)

Exclusion Criteria

* 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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No