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

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.

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

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