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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.
Patients with a biochemical recurrence after initial therapy can be included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peptide vaccine | Experimental | Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 |
|
| Peptide vaccine + GM-CSF | Experimental | Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Granulocyte macrophage colony stimulating factor (GM-CSF) |
|
| Peptide vaccine + local hyperthermia | Experimental | Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia |
|
| Peptide vaccine + Imiquimod | Experimental | Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod |
|
| Peptide vaccine + mRNA/Protamin | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peptide vaccine | Biological | subcutaneous |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnulf Stenzl, Prof. | Department of Urology, University of Tuebingen | Principal Investigator |
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Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin |
|
| Montanide ISA-51 | Drug | subcutaneous |
|
| Granulocyte macrophage colony stimulating factor (GM-CSF) | Drug | intradermal |
|
| Imiquimod | Drug | epicutaneous |
|
| mRNA | Drug | subcutaneous |
|
| Protamin | Drug | subcutaneous |
|
| local hyperthermia | Procedure |
|
| Months 0-60 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000096202 | Protein Subunit Vaccines |
| C477385 | montanide ISA 51 |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D000077271 | Imiquimod |
| D012333 | RNA, Messenger |
| C029997 | somatostatin, protamine zinc- |
| D006979 | Hyperthermia, Induced |
| ID | Term |
|---|---|
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012313 | RNA |
| D009696 | Nucleic Acids |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013812 | Therapeutics |
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