NCT04390880已完成2 期
IMPACT OF 18F-DCFPyL PET/CT ON INITIAL AND SUBSEQUENT TREATMENT STRATEGIES OF PATIENTS WITH PROSTATE CANCER (PROSPYL)
VA Greater Los Angeles Healthcare System1 个研究点 分布在 1 个国家目标入组 239 人开始时间: 2020年4月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- PRIMARY OBJECTIVES: I. To Determine the Impact of 18F-DCFPyL PET/CT on Initial and Subsequent Treatment Strategies of Patients With Prostate Cancer.
研究概览
简要总结
The main purpose of this phase II trial study is to determine whether a positron emission tomography (PET)/computed tomography (CT) scan using 18F-DCFPyL affects the clinical management plan in Veterans.
In this study, the management plan prior to and after 18F-DCFPyL PET/CT will be recorded by specific questionnaires and corresponding changes in management will be analyzed. The scan will be used to see how the disease has spread. Both the treatment strategies and probable disease outcomes as relevant to clinical endpoints will be assessed. This study is open to Veterans only.
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
- •Participants who fulfill criteria for initial staging or restaging as outlined below:
- •Initial treatment strategy decisions (initial staging)
- •All participants with histologically proven prostate cancer or strong suspicion of prostate adenocarcinoma based on very high PSA levels (>50 ng/mL) who require an initial treatment/management decision who may be candidate for any of the following strategies:
- •A) Surgery B) External radiation therapy (RT) C) Other focal therapies D) Systemic medical treatment E) Watchful waiting
- •Assessment for Subsequent treatment strategy (restaging), any of the following:
- •A) Participants with biochemical recurrence who are potential candidates for any salvage treatment. Biochemical recurrence is defined by rising PSA after definitive therapy with prostatectomy or radiation therapy, as any of the following:
- •Post radical prostatectomy (RP): PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
- •Post-radiation therapy : Nadir + greater than or equal to 2 ng/mL rise in PSA B) Participants with known prostate cancer who undergo restaging because of new symptoms C) Participants with known metastatic prostate cancer who undergo restaging because of rising PSA with negative or inconclusive conventional imaging D) Participants with known prostate cancer who are treated medically or with RLT in whom response to treatment is assessed
- •Capability to provide written informed consent
- •Able to remain still for duration of each imaging procedure (about 30 minutes) * Participants may be reenrolled in the study, if 18F-DCFPyL PET/CT is performed for subsequent management decision.
排除标准
- •Less than 18 years-old at the time of radiotracer administration
- •Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- •Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
- •Inability to provide written informed consent
研究组 & 干预措施
PEt/CT arm
Experimental
Subjects receive a PET/CT scan.
干预措施: 18F-DCFPyL (Drug)
结局指标
主要结局
PRIMARY OBJECTIVES: I. To Determine the Impact of 18F-DCFPyL PET/CT on Initial and Subsequent Treatment Strategies of Patients With Prostate Cancer.
时间窗: 6 months
the percentage of patients whose management was changed after PSMA PET/CT
次要结局
未报告次要终点
研究者
研究点 (1)
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