NCT05751941进行中（未招募）2 期
A Phase II Randomized Study of Sipuleucel-T With or Without Continuing New Hormonal Agents (NHA) in Metastatic Prostate Cancer With PSA Progression While on NHA and LHRH Analog
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Cumulative APC Activation
研究概览
简要总结
This study is designed to test the hypothesis that using Sipuleucel-T (Provenge) in combination with new hormonal agents (NHA) (abiraterone, enzalutamide, apalutamide) for the treatment of participants with asymptomatic metastatic castration resistant prostate cancer (mCRPC) and no visceral metastases would enhance the activation of antigen presenting cells (APC) by sipuleucel-T.
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
- •Asymptomatic or minimally symptomatic metastatic prostate cancer, and the diagnosis of prostate cancer needs to be histologically confirmed by biopsy of the prostate or a metastatic lesion
- •On combined ADT with LHRH analog and a NHA (enzalutamide, apalutamide or abiraterone) for metastatic prostate cancer with PSA progression, but no imaging progression based on the prostate cancer working group (PCWG) 3 criteria
- •Age 18 or above
- •ECOG performance status 0 or 1
- •Participants must have adequate organ and marrow function as defined below:
- •Absolute neutrophil count ≥1,000/mcL
- •Platelets ≥100,000/mcL
- •Hemoglobin > 10 g/dl
- •AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
- •Creatinine 1.5 ≤ institutional ULN
- •Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- •For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- •Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- •Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of sipuleucel-T are eligible for this trial
- •No uncontrolled arrhythmia: patients with h/o myocardial infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or MUGA scan within 6 months of study enrollment
- •Non-sterilized men who are sexually active with a female partner of childbearing potential must agree to use adequate contraception prior to the study enrollment, and for the duration of study participation
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
- •Prior treatment with sipuleucel-T
- •Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 2).
- •Participants who require > 50% dose reduction of NHA are excluded from the study except for taking abiraterone at 250 mg with low fat food
- •Documented brain metastases or liver metastases
- •Treatment with any investigational compound within 30 days prior to the first dose of Sipuleucel-T
- •Documented brain metastases or liver metastases
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome. HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for sipluleucel-T to be less clinically active in this population
- •Inability to comply with protocol requirements
研究组 & 干预措施
Sipuleucel-T with NHA
Experimental
Participants will continue taking New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.
干预措施: Enzalutamide (Drug)
Sipuleucel-T with NHA
Experimental
Participants will continue taking New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.
干预措施: Abiraterone (Drug)
Sipuleucel-T with NHA
Experimental
Participants will continue taking New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.
干预措施: Apalutamide (Drug)
Sipuleucel-T with NHA
Experimental
Participants will continue taking New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.
干预措施: Sipuleucel-T (Drug)
Sipuleucel-T without NHA
Experimental
Participants will discontinue use of New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.
干预措施: Sipuleucel-T (Drug)
结局指标
主要结局
Cumulative APC Activation
时间窗: At Week 4
Cumulative APC activation is calculated as the sum of APC activation across 0, 2, and 4 weeks
次要结局
- Time to PSA progression(Up to week 44)
- Radiographic Progression Free Survival(Up to week 44)
- IgG Responses(At week 14)
研究者
研究点 (2)
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