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177Lu放射性标记单克隆抗体HuJ591（177Lu-J591）与酮康唑在前列腺癌患者中的疗效

2026年10月21日 更新者：Weill Medical College of Cornell University

177Lu 放射性标记单克隆抗体 HuJ591 (177Lu-J591) 和酮康唑在局部治疗后高危去势生化复发前列腺癌患者中的随机 2 期试验

The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591 in combination with ketoconazole and hydrocortisone against prostate cancer.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

This research is being done because the standard treatments for prostate cancer that has returned (PSA is elevated) after surgery and/or radiation and progressed on initial hormonal therapy are not curative. Existing treatments, such as the ketoconazole used as part of this study may decrease PSA temporarily, but unfortunately the cancer continues to grow. This experimental drug is designed to seek out all of the prostate cancer cells and to deliver a lethal dose of radiation to the areas of cancer, but not to normal areas. Some of the normal organs (liver, kidney and bone marrow) do receive some radiation dose that is within the acceptable limits.

The experimental drug in this study includes an antibody (abbreviated: mAb) called "J591". It is a protein molecule which can bind to a specific site on a prostate cancer cell. A very energetic radioactive (an unstable atom) metal called 177Lutetium (abbreviated: 177Lu) is attached to the J591 antibody. The fully assembled drug is called "177Lu-J591". The study will assess the potential of the energy given off by the radioactive compound to kill cancer cell. This study may also involve the use of 111Indium (abbreviated 111In). This is also an energetic radioactive particle, but does not generally give off enough energy to kill cancer cells, but allows researchers to take pictures. This radioactive particle is also attached to the J591 antibody (called 111In-J591) and will serve as a placebo (treatment with no active medicine).

研究类型

介入性

注册 (实际的)

55

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Los Angeles、California、美国、90048
        • Cedars Sinai
      • Los Angeles、California、美国、90089
        • USC/Norris Comprehensive cancer center
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20007
        • Georgetown University Medical Center
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • Indiana University Melvin and Bren Simon Cancer Center
    • Iowa
      • Iowa City、Iowa、美国、52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Westwood、Kansas、美国、66205
        • The University of Kansas Cancer Center
    • Nebraska
      • Omaha、Nebraska、美国、68130
        • XCancer Omaha
    • New York
      • New York、New York、美国、10021
        • Weill Cornell Medical College
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15232
        • UPMC Hillman Cancer Center
    • Utah
      • Salt Lake City、Utah、美国、84108
        • University of Utah

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or radiotherapy.

  • Biochemical progression (rising PSA) after medical or surgical castration

  • High risk of systemic progression defined as:

    1. Rising PSA as defined above and either:
    2. Absolute PSA > 20 ng/mL AND/OR
    3. PSA doubling time < 8 months

  • No evidence of local recurrence or distant metastases

  • Age >18 years.

  • Serum testosterone < 50 ng/ml

  • Patients capable of fathering children must agree to use an effective method of contraception for the duration of the trial.

  • Subjects on bisphosphonate therapy must be on a stable dose and must have started therapy > 4 weeks prior to protocol therapy.

  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Use of red blood cell or platelet transfusions within 4 weeks of treatment

  • Use of hematopoietic growth factors within 4 weeks of treatment

  • Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment

  • Prior radiation therapy encompassing >25% of skeleton (see Appendix C)

  • Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®)

  • Platelet count <150,000/mm3 or known primary qualitative platelet disorder

  • Absolute neutrophil count (ANC) <2,000/mm3

  • Hematocrit <30 percent and Hemoglobin < 10 g/dL

  • Abnormal coagulation profile (PT or INR, PTT > 1.3x ULN) unless on therapeutic anticoagulation - see concomitant meds section

  • Serum creatinine >2.5 mg/dL

  • AST (SGOT) >2x ULN

  • Bilirubin (total) >1.5x ULN; subjects with Gilbert's syndrome will be allowed if direct bilirubin is within institutional normal limits

  • Active serious infection

  • Active angina pectoris or NY Heart Association Class III-IV

  • ECOG Performance Status > 2

  • Life expectancy <12 months

  • History of deep vein thrombosis and/or pulmonary embolus within 1 month of study entry

  • Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study

  • Prior investigational therapy (medications or devices) within 4 weeks of treatment. Furthermore, other investigational therapy is not permitted during the treatment phase.

  • Prior use of ketoconazole for the purposes of prostate cancer therapy for greater than 1 month

  • Known history of HIV. The effects of J591 are unknown in this population. Furthermore, ketoconazole has many well-described drug-drug interactions which could affect antiviral therapy. If necessary, this population will be studied separately.

  • Currently active other malignancy other than non-melanoma skin cancer. Patients are considered not to have "currently active" malignancy if they have completed any necessary therapy and are considered by their physician to be at less than 30% risk of relapse.

    - Known history of known myelodysplastic syndrome

  • Adrenal hormone inhibitors (other than ketoconazole) within 4 weeks prior to study enrollment

  • Finasteride (Propecia® or Proscar®) or dutasteride (Avodart®) within 4 weeks of enrollment

  • Patients on corticosteroids prior to enrollment must have either discontinued and shown biochemical progression or have biochemical progression on a stable dose

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：1. 177Lu-J591 + Ketoconazole

Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 177Lu-J591 Infusion, continue ketoconazole and hydrocortisone
药品：177Lu-J591

177Lu-J591 70 mCi/m2 on day 29 (+/- 2 days) of treatment

其他名称：
  • J591
药品：Ketoconazole

Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)

其他名称：
  • 尼佐拉尔
药品：Hydrocortisone

Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)

其他名称：
  • 科尔特夫
安慰剂比较：2. 111In-J591 + Ketoconazole

Ketoconazole 400 mg 3 times a day plus hydrocortisone 20 mg AM, 10 mg PM x 4 weeks followed by 111In-J591 (placebo) Infusion, continue ketoconazole and hydrocortisone
药品：Ketoconazole

Ketoconazole at a dose of 400 mg (two 200 mg tabs) to be taken orally (preferably on an empty stomach) three times per day (total daily dose of 1200 mg)

其他名称：
  • 尼佐拉尔
药品：Hydrocortisone

Hydrocortisone at a dose of 20 mg orally each morning, 10 mg orally each evening (total daily dose of 30 mg)

其他名称：
  • 科尔特夫
药品：111In-J591

111In-J591 at a dose of 5 mCi on day 29 (+/- 2 days) of treatment

其他名称：
  • J591

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Proportion of Participants Free of Radiographically Evident Metastases From Baseline to 18 Months After Study Drug Administration
大体时间：Baseline and 18 months after study drug administration

Subjects will perform a CT and/or MRI scan of the abdomen and pelvis, chest x-ray or CT scan of the chest and bone scan to determine the proportion of participants free of radiographically evident metastases from baseline to 18 months after study drug administration.
Baseline and 18 months after study drug administration

次要结果测量

结果测量
措施说明
大体时间
Change in PSA Response Rate
大体时间：Collected at screening, V2, V3, V5, V9 then every 4 weeks till PSA progression or end of study at approximately 100 months

PSA response will be determined by comparing the PSA levels after therapy to the baseline and pre-treatment PSA via blood specimens
Collected at screening, V2, V3, V5, V9 then every 4 weeks till PSA progression or end of study at approximately 100 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Weill Medical College of Cornell University

合作者

United States Department of Defense

调查人员

  • 首席研究员：Scott T Tagawa, M.D.、Weill Medical College of Cornell University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2009年6月1日

初级完成 (实际的)

2022年2月10日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2009年3月10日

首先提交符合 QC 标准的

2009年3月10日

首次发布 (估计的)

2009年3月11日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年10月21日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 0810010067
  • J591+Ketoconazole (其他标识符：Weill Cornell Medicine)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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