Evaluation of Lymph Node Metastases in Men Undergoing Treatment With Sipuleucel-T for Metastatic Castrate-resistant Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- anti-PA2024 immune response in lymph node-derived leukocytes
研究概览
简要总结
This study aims to evaluate patients with metastatic castrate-resistant prostate cancer (mCRPC) undergoing treatment with sipuleucel-T for evidence of treatment-associated immune activation in lymph nodes and peripheral blood.
详细描述
This is a pilot study of mCRPC patients planning to undergo therapy with sipuleucel-T immunotherapy. Consenting patients will be randomized 3:1 between immediate sipuleucel-T immunotherapy followed by lymph node biopsy (the post-treatment experimental group) or immediate lymph node biopsy followed by sipuleucel-T immunotherapy (the pre-treatment control group). Peripheral blood will be collected before, during, and after treatment with sipuleucel-T and evaluated for evidence of sipuleucel-T induced immune activation. Lymph nodes collected at biopsy will also be evaluated for evidence of sipuleucel-T induced immune activation. Patients will be followed for 3 months for safety and 6 months for disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age ≥ 18 years
- •ECOG performance status 0 or 1
- •Life expectancy of ≥ 6 months
- •Minimally-symptomatic or asymptomatic, castrate-resistant metastatic prostate cancer, as evidenced by all of the following:
- •Histologically-confirmed diagnosis of adenocarcinoma of the prostate
- •Evidence of adequate androgen deprivation, as evidence by one of the following:
- •Bilateral orchiectomy
- •Ongoing LHRH agonist (e.g. leuprolide, goserelin) and serum testosterone <50 ng/dl
- •Ongoing LHRH antagonist (e.g. degarelix) and serum testosterone <50 ng/dl
- •Evidence of prostate cancer resistance to castration, as evidenced by one of the following:
- •2 consecutive PSA levels that are ≥ 50% above the PSA nadir achieved on ADT and obtained at least 1 week apart
- •CT or MRI based evidence of disease progression (soft tissue or nodal) according to PCWG2 criteria or RECIST 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies.
- •Presence of non-visceral metastases on imaging
- •Absence of major symptoms directly attributable to prostate cancer, with the following permissible exceptions:
- •Ureteral obstruction secondary to pelvic or retroperitoneal lymphadenopathy
- •Bladder outlet obstruction secondary to locally recurrent prostate cancer
- •Radiographic evidence of lymphadenopathy, defined as a lymph node greater than 1 cm in diameter on axial imaging (CT or MRI or PET/CT)
- •Adequate laboratory parameters
- •A minimum of 4 weeks from any major surgery prior to registration. Coincident standard of care surgery with the research biopsy is permitted during the study.
排除标准
- •Prior treatment with sipuleucel-T
- •Allergy to any component of sipuleucel-T
- •Inability to undergo leukapheresis
- •History of neuroendocrine variants of prostate cancer, including small cell carcinoma of the prostate
- •Extensive prior surgery/radiation present that would render the biopsy highly complex and the risk of intraoperative injury high
- •Any chronic medical condition requiring daily corticosteroids or other immunosuppressants
- •Solid organ transplantation requiring immunosuppression
- •Visceral (e.g. lung, liver) metastases
- •Known brain metastases
- •History of spinal cord compression
- •Untreated/unstabilized pathologic long bone fractures
- •Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months
- •Administration of any investigational therapeutic within 30 days of registration
- •Any condition which, in the opinion of the investigator, would preclude participation in this trial
研究组 & 干预措施
Arm A
Pre-treatment control group will be randomized to immediate lymph node biopsy followed by sipuleucel-T immunotherapy.
干预措施: Sipuleucel-T (Drug)
Arm A
Pre-treatment control group will be randomized to immediate lymph node biopsy followed by sipuleucel-T immunotherapy.
干预措施: Lymph Node Biopsy (Procedure)
Arm B
Post-treatment experimental group will be randomized to immediate sipuleucel-T immunotherapy followed by lymph node biopsy.
干预措施: Sipuleucel-T (Drug)
Arm B
Post-treatment experimental group will be randomized to immediate sipuleucel-T immunotherapy followed by lymph node biopsy.
干预措施: Lymph Node Biopsy (Procedure)
结局指标
主要结局
anti-PA2024 immune response in lymph node-derived leukocytes
时间窗: Lymph node biopsy, approximately 10 weeks
Proportion of patients with lymph node-derived leukocytes showing anti-PA2024 activity as measured by IFNγ ELISPOT
anti-PAP immune response in lymph node-derived leukocytes
时间窗: Lymph node biopsy, approximately 10 weeks
Proportion of patients with lymph node-derived leukocytes showing anti-PAP activity as measured by IFNγ ELISPOT
anti-PAP immune response in PBMCs
时间窗: 6 months post-treatment
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
anti-PA2024 immune response in PBMCs
时间窗: 6 months post-treatment
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
次要结局
- Serum anti-PA2024 antibody level(Baseline, up to 6 months post-treatment)
- serum anti-PAP antibody level(Baseline, up to 6 months post-treatment)