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

University Hospital Tuebingen

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Recurrent Prostate Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02452307

167/2003

Details and patient eligibility

About

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.

Full description

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

Enrollment: 36 patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 5 patient groups

Peptide vaccine

Experimental group

Description:

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

Treatment:

Drug: Montanide ISA-51

Biological: Peptide vaccine

Peptide vaccine + GM-CSF

Experimental group

Description:

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

Treatment:

Drug: Montanide ISA-51

Biological: Peptide vaccine

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

Peptide vaccine + local hyperthermia

Experimental group

Description:

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

Treatment:

Drug: Montanide ISA-51

Procedure: local hyperthermia

Biological: Peptide vaccine

Peptide vaccine + Imiquimod

Experimental group

Description:

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

Treatment:

Drug: Imiquimod

Drug: Montanide ISA-51

Biological: Peptide vaccine

Peptide vaccine + mRNA/Protamin

Experimental group

Description:

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

Treatment:

Drug: Montanide ISA-51

Drug: Protamin

Biological: Peptide vaccine

Drug: mRNA