Prospective Randomized Trial of Peptide-specific Vaccination in HLA-A*02 Positive Prostate Carcinoma Patients With Biochemical Recurrence After Radical Prostatectomy
试验速览
- 阶段
- 1 期
- 入组人数
- 36
- 主要终点
- Change from Baseline in Immune Response at day 70
研究概览
简要总结
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.
详细描述
Patients with a biochemical recurrence after initial therapy can be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Peptide vaccine
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51
干预措施: Peptide vaccine (Biological)
Peptide vaccine
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51
干预措施: Montanide ISA-51 (Drug)
Peptide vaccine + GM-CSF
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Granulocyte macrophage colony stimulating factor (GM-CSF)
干预措施: Peptide vaccine (Biological)
Peptide vaccine + GM-CSF
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Granulocyte macrophage colony stimulating factor (GM-CSF)
干预措施: Montanide ISA-51 (Drug)
Peptide vaccine + GM-CSF
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Granulocyte macrophage colony stimulating factor (GM-CSF)
干预措施: Granulocyte macrophage colony stimulating factor (GM-CSF) (Drug)
Peptide vaccine + local hyperthermia
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia
干预措施: Peptide vaccine (Biological)
Peptide vaccine + local hyperthermia
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia
干预措施: Montanide ISA-51 (Drug)
Peptide vaccine + local hyperthermia
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with local hyperthermia
干预措施: local hyperthermia (Procedure)
Peptide vaccine + Imiquimod
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod
干预措施: Peptide vaccine (Biological)
Peptide vaccine + Imiquimod
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod
干预措施: Montanide ISA-51 (Drug)
Peptide vaccine + Imiquimod
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with Imiquimod
干预措施: Imiquimod (Drug)
Peptide vaccine + mRNA/Protamin
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin
干预措施: Peptide vaccine (Biological)
Peptide vaccine + mRNA/Protamin
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin
干预措施: Montanide ISA-51 (Drug)
Peptide vaccine + mRNA/Protamin
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin
干预措施: mRNA (Drug)
Peptide vaccine + mRNA/Protamin
Subcutaneous application of Prostate-specific peptide vaccine compound emulsified in Montanide ISA-51 in combination with mRNA/Protamin
干预措施: Protamin (Drug)
结局指标
主要结局
Change from Baseline in Immune Response at day 70
时间窗: Days 0-70
Immune Response, as measured by the change of in vitro and in vivo T cell response from baseline at day 0 to day 70
次要结局
- Tolerability(Days 0-420)
- Treatment response(Months 0-60)