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

Study Overview
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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.

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

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

Conditions
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Recurrent Prostate Cancer

Intervention / Treatment
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* Biological: Peptide vaccine
* Drug: Montanide ISA-51
* Drug: Granulocyte macrophage colony stimulating factor (GM-CSF)
* Drug: Imiquimod
* Drug: mRNA
* Drug: Protamin
* Procedure: local hyperthermia


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peptide vaccine<br>Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 | Biological: Peptide vaccine<br>* subcutaneous<br>Drug: Montanide ISA-51<br>* subcutaneous<br>|
| Experimental: Peptide vaccine + GM-CSF<br>Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Granulocyte macrophage colony stimulating factor (GM-CSF) | Biological: Peptide vaccine<br>* subcutaneous<br>Drug: Montanide ISA-51<br>* subcutaneous<br>Drug: Granulocyte macrophage colony stimulating factor (GM-CSF)<br>* intradermal<br>|
| Experimental: Peptide vaccine + local hyperthermia<br>Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia | Biological: Peptide vaccine<br>* subcutaneous<br>Drug: Montanide ISA-51<br>* subcutaneous<br>Procedure: local hyperthermia<br> <br> |
| Experimental: Peptide vaccine + Imiquimod<br>Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod | Biological: Peptide vaccine<br>* subcutaneous<br>Drug: Montanide ISA-51<br>* subcutaneous<br>Drug: Imiquimod<br>* epicutaneous<br>|
| Experimental: Peptide vaccine + mRNA/Protamin<br>Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin | Biological: Peptide vaccine<br>* subcutaneous<br>Drug: Montanide ISA-51<br>* subcutaneous<br>Drug: mRNA<br>* subcutaneous<br>Drug: Protamin<br>* subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Days 0-70 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability | Tolerability, as measured by number of Participants with Adverse Events | Days 0-420 | 
| Treatment response | Treatment response, from date of randomization until the date of first documented progression as measured by PSA-value | Months 0-60 |