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

• Status: Unknown status
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Treatments: Freund's Adjuvant; Imiquimod; Molgramostim; Protamines; Sargramostim; Vaccines

Criteria

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