A Randomized, Open-Label, Phase 2 Trial Examining the Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men With Non-metastatic Prostate Cancer and a Rising Serum Prostate Specific Antigen After Primary Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 14
- 主要终点
- Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024
研究概览
简要总结
The main purpose of this study was to determine whether ADT started before or after sipuleucel-T led to a better immune system response. This study also evaluated the safety of sipuleucel-T and ADT treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.
详细描述
Multicenter, randomized, open-label study, with subjects allocated (1:1) to 1 of 2 study arms, using a stratified randomization based on:
• Prostate-specific antigen doubling time (PSADT): ≤ 3 months or > 3 months and ≤ 12 months. • Primary therapy: radical prostatectomy (RP) or radiation, including brachytherapy, (XRT) or RP + XRT.
Arm 1: Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
Arm 2: Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
Cellular and humoral immune responses were assessed for Arm 2 subjects at 12, 8, and 4 weeks pre infusion 1, and in all subjects (both arms) at pre-leukapheresis 1, 2, and 3, and post-infusion 1, 2 and 3, and at the following time points after the third infusion: Weeks 2, 6, and 12 and Months 6, 9, 12, 15, 18, 21, and 24.
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
- •Hormone-sensitive prostate cancer
- •Non-metastatic disease, as evidenced by negative bone scan or computed tomography of the abdomen and pelvis
- •ECOG performance status ≤ 1
- •Histologically documented prostate cancer
- •Prior primary therapy for prostate cancer
- •Rising PSA with a PSADT of ≤ 12 months
- •Testosterone ≥ 200 ng/dL ≤ 28 days of registration
- •Adequate hematologic, renal, and liver function
- •Must live in a permanent residence within a comfortable driving distance (round-trip within one day) to the clinical research site
排除标准
- •Requires systemic ongoing immunosuppressive therapy
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF
- •Prior sipuleucel-T therapy
- •Prior ADT therapy ≤ 6 months prior to registration or ≥ 6 months duration in total
- •If subject has a history of any other stage III/IV malignancy, the subject must be disease free and off any malignancy-related treatment for at least 10 years. If the subject has a history of any stage I-II malignancy, the subject must be disease free and off any malignancy-related treatment for at least 5 years.
- •Prior experimental immunotherapy or on an experimental clinical trial within 1 year
- •Received denosumab or XRT ≤ 6 months prior to registration
- •Received chemotherapy or GM-CSF ≤ 90 days prior to registration
- •Received any of the following medications or interventions ≤ 28 days prior to registration
- •major surgery requiring general anesthesia
- •systemic immunosuppressive therapy
- •other prescription treatment for prostate cancer
- •Active infection within 1 week of registration
- •Likely to receive XRT or surgery for prostate cancer during the study period
- •Any medical intervention, any other condition, or any circumstances that could compromise the study.
研究组 & 干预措施
Arm 2: ADT followed by sipuleucel-T
Arm 2: Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
干预措施: leuprolide acetate (Drug)
Arm 2: ADT followed by sipuleucel-T
Arm 2: Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
干预措施: sipuleucel-T (Biological)
Arm 1: Sipuleucel-T followed by ADT
Arm 1: Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
干预措施: leuprolide acetate (Drug)
Arm 1: Sipuleucel-T followed by ADT
Arm 1: Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
干预措施: sipuleucel-T (Biological)
结局指标
主要结局
Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024
时间窗: PA2024 ELISPOT counts at Month 24
Immune response at month 24 as evaluated by IFN-γ ELISPOT specific for PA2024 following sipuleucel-T/ADT treatment regimens to determine if order of administration impacted immune response.
次要结局
- Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024(Month 24)