An Open Label, Phase 2 Trial of Immunotherapy With Sipuleucel-T (Provenge®) as Neoadjuvant Treatment in Men With Localized Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 14
- 主要终点
- Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
研究概览
简要总结
This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.
详细描述
This is a single center, open label, Phase 2 study. Subjects will be treated with 3 infusions of sipuleucel-T prior to a scheduled radical prostatectomy (RP) surgery. To assess the immune response following treatment with sipuleucel-T, tissue from the prostatectomy specimen will be compared with tissue from the core biopsy specimen obtained prior to treatment with sipuleucel T. Following RP, subjects will be randomized to receive either a booster infusion of sipuleucel T or no further treatment with sipuleucel-T (i.e., booster: no booster).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adenocarcinoma of the prostate.
- •Subject is scheduled for RP as the initial therapy for localized prostate cancer.
- •Subject is ≥ 18 years of age.
- •Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Subject has adequate hematologic, renal, and liver function.
排除标准
- •Subject has any evidence of metastasis.
- •Subject received hormones, including luteinizing hormone-releasing hormone agonists, antiandrogens, or 5 α-reductase inhibitors at any time prior to study screening.
- •Subject has received prior radiation therapy or chemotherapy for prostate cancer.
- •Subject has received systemic steroid therapy within 14 days.
- •Subject has a history of stage III or greater cancer, excluding prostate cancer.
- •Subjects with a history of basal or squamous cell skin cancers are allowed, provided that the subject was adequately treated and is disease-free at the time of study screening.
- •Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years prior to study screening.
结局指标
主要结局
Change in the Number of Infiltrating CD3+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject
时间窗: Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment)
CD3+ T cell infiltration within prostate tissue was quantified using immunohistochemistry (IHC) staining techniques. Cells were enumerated per unit area (cells/μm2). For post-RP tissue specimens, three areas of interest were identified: Benign tissue, tumor tissue, and tumor interface tissue.
次要结局
- Change in the Number of Infiltrating CD4+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject(Pre-treatment biopsy (baseline) and post-RP (12 weeks post-treatment))
- Change in Antigen PA2024-specific T Cell Immunity in Peripheral Blood(Baseline (screening visit) and up to 12-weeks post-RP visit (24 weeks following sipuleucel-T))
- Change in Antigen PAP-specific T Cell Immunity in Peripheral Blood(Baseline (screening visit) and up to 12-weeks post-RP visit (24 months post sipuleucel-T))
- Change in the Number of Infiltrating CD8+ T Cells Within the Prostate Tissue Between the Biopsy and the Post-RP Tissue Specimens in Each Subject(Pre-treatment biopsy (baseline) and post-RP (12 weeks following sipuleucel-T))
- Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PA2024-Specific T Cell Immunity in the Peripheral Blood.(12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP)
- Effect of a Post-RP Booster Infusion of Sipuleucel-T Over Time of Antigen PAP-Specific T Cell Immunity in the Peripheral Blood.(12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP)
- Comparison of Booster Effect in Antigen PA2024-Specific T Cell Immunity Over Time Between the Two Randomized Groups(12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP)
- Comparison of Booster Effect in Antigen PAP-Specific T Cell Immunity Over Time Between the Two Randomized Groups(12 Weeks Post-RP (Pre-booster) and up to 72 Weeks post-RP)