Expanded Access Protocol of 68Ga-PSMA-11 for PET Imaging
2021年6月21日 更新者：Jonsson Comprehensive Cancer Center
Expanded Access Protocol of 68Ga-PSMA-11 for Prostate Cancer PET Imaging
To provide expanded access to 68Ga-PSMA-11 PET imaging for eligible participants to detect and localize prostate cancer for initial and subsequent treatment strategy.
研究概览
详细说明
Prostate-specific membrane antigen (PSMA) targeted Positron Emission Tomography (PET) imaging has been embraced enthusiastically worldwide.
Given the unmet clinical need for accurately diagnosing and staging prostate cancer and the encouraging results of 68Ga-PSMA-11 PET worldwide, University of California Los Angeles (UCLA) and University of California San Francisco (UCSF) conducted pivotal registration trials to assess 68Ga-PSMA-11's safety and efficacy profile in detecting prostate cancer in adult patients.
To gap the unmet clinical need of 68Ga-PSMA-11 PET during the period prior to FDA approval, UCLA Nuclear Medicine offers expanded access of this investigational PET drug to eligible participants.
研究类型
扩展访问
扩展访问类型
- 个体患者
- 中型人口
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
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California
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Los Angeles、California、美国、90095
- University of California at Los Angeles
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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
不适用
有资格学习的性别
男性
描述
Biochemical recurrent (i. Inclusion/Exclusion) and preprostatectomy (ii. Inclusion/Exclusion) staging patients will be eligible for the expanded access protocol. In order to be eligible to participate in this study, an individual must meet the following criteria:
Biochemical Recurrence Population:
i. Inclusion Criteria:
- Histopathological proven prostate adenocarcinoma.
Rising prostatic specific antigen(PSA) after definitive therapy with prostatectomy or radiation therapy.
- Post radical prostatectomy (RP)
- PSA equals to or greater than 0.2 ng/mL measured more than 6weeks after RP
- Post-radiation therapy -ASTRO-Phoenix consensus definition
- Nadir + greater than or equal to 2 ng/mL rise in PSA
- Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group (ECOG)/ World Health Organization (WHO) equivalent).
- Age > 18.
Ability to understand a written informed consent document, and the willingness to sign it.
i. Exclusion Criteria:
- Concomitant investigational therapy.
- Known inability to lie flat, remain still or tolerate a PET scan.
- Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
Preprostatectomy Staging Population:
ii. Inclusion criteria:
- Biopsy proven prostate adenocarcinoma.
- Considered for prostatectomy with lymph node dissection.
- Intermediate to high-risk disease (as determined by elevated PSA [PSA>10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors).
- Able to provide written consent.
- Karnofsky performance status of ≥50 (or ECOG/WHO equivalent).
ii. Exclusion criteria:
- Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
- Neoadjuvant chemotherapy, radiation therapy or any definitive local therapy prior to prostatectomy including focal ablation techniques (HiFu).
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？
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。
调查人员
- 首席研究员：Jeremie Calais, M.D.、University of California at Los Angeles
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。
研究注册日期
首次提交
2020年3月13日
首先提交符合 QC 标准的
2020年4月15日
首次发布 (实际的)
2020年4月16日
研究记录更新
最后更新发布 (实际的)
2021年6月24日
上次提交的符合 QC 标准的更新
2021年6月21日
最后验证
2021年6月1日
更多信息
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.