NCT03800784撤回2 期
Study of 18F-DCFPyL PET/CT, for Detection of Radiological Progression in Patients With Metastatic (M+) and Non-metastatic (M0) Castration Resistant Prostate Cancer Receiving Standard Androgen Receptor Targeted Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Sensitivity 18F-DCFPyL PET/CT imaging to detect metastatic prostate cancer
研究概览
简要总结
This study evaluates the rate of radiological disease progression with the new 2nd generation positron emission tomography (PET) radiopharmaceutical, 18F-DCFPyL, in patients with metastatic castration (mCRPC) and non-metastatic (nmCRPC) castration resistant prostate cancer who have evidence of biochemical (PSA) disease progression without evidence of radiological disease progression on conventional standard radiologic testing (99mTc-methylene diphosphonate bone scan and CT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Histological confirmation of prostate cancer
- •Patients receiving androgen deprivation treatment (ADT) with GnRH analogs, GnRH antagonists or bilateral orchiectomy of any duration.
- •Cohort A: nmCRPC (status post- primary treatment with radical prostatectomy, radiation of any type or both)
- •Negative 99mTc-methylene diphosphonate bone scan and CT of the chest abdomen and pelvis within 6 weeks of 18F-DCFPyL PET/CT
- •Treatment with ADT with or without a second line novel AR targeted treatment (abiraterone, enzalutamide, or both) or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted) for ≥ 12 months.
- •Rising PSA ≥ 10 ng/ml (confirmed by 2 determinations one week apart)
- •PSADT ≤ 9 months
- •Cohort B: mCRPC
- •Treatment with ADT with or without abiraterone and or enzalutamide or both for ≥ 6 months and/or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted).
- •PSA ≥ 2.0 ng/ml confirmed X 1 week apart, any PSADT
- •Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility.
- •No new therapeutic interventions planned or scheduled to be instituted prior to the course of this study both on cohorts A and B before conventional radiologic progression is evidenced.
- •Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.
排除标准
- •Patient will be excluded from enrollment if he had a radioisotope within 5 physical half-lives prior to PET imaging
研究组 & 干预措施
18F-DCFPyL Injection
Experimental
A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
干预措施: 18F-DCFPyL Injection (Drug)
结局指标
主要结局
Sensitivity 18F-DCFPyL PET/CT imaging to detect metastatic prostate cancer
时间窗: 3 years
Proportion of patients demonstrating disease progression by conventional criteria evaluated by CT scan and 99mTc-methylene diphosphonate bone scan and on 18F-DCFPyL PET/CT.
次要结局
- Correlation of findings on 18F-DCFPyL PET/CT with conventional imaging as determined by Number of Lesions detected on each imaging modality(3 years)
研究者
研究点 (1)
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