Prospective Study Evaluating the Role of Axumin® (Fluciclovine or 18F-FACBC) PET in Patients With Biochemical Recurrence of Prostate Cancer and a Negative PSMA PET
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of participants with BCR and a positive Fluciclovine PET performed within 30 days after a negative or equivocal PSMA PET
研究概览
简要总结
The purpose of this prospective cohort study is to investigate the role of Fluciclovine Positron Emission Tomography (PET) in patients with biochemical recurrence of prostate cancer (BCR) and a negative Prostate Specific Membrane Antigen (PSMA) PET, specifically, whether Fluciclovine PET can help detect local recurrence and whether the results of Fluciclovine PET can change management.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the detection rate of local recurrence of prostate cancer on Fluciclovine PET in patients with BCR and a negative or equivocal PSMA PET obtained within 30 days prior to the Fluciclovine PET.
SECONDARY OBJECTIVES:
I. To evaluate the correct localization rate of Fluciclovine PET in patients with positive scans.
II. To distinguish the detection rate by site of recurrence (local recurrence in the prostate bed, lymph node involvement, or distant metastatic disease), and stratify by PSA level at the time of the scan and tumor grade
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
- •Age >= 18 years.
- •Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed.
- •Patients with suspected BCR of prostate cancer after initial treatment, and a negative or equivocal PSMA PET, regardless of the findings on conventional imaging. Initial treatment may include prostatectomy and/or radiation therapy.
- •PSA of 0.2 ng/mL or higher within 45 days of the scan.
排除标准
- •Uncontrolled serious infection.
- •Intercurrent illness or condition that would limit compliance with study requirements.
- •Patients who have started any cancer treatment (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the PSMA PET and Axumin PET/CT scans.
研究组 & 干预措施
Fluciclovine PET/CT
Participants will undergo Fluciclovine PET/CT within 30 days of a negative or equivocal PSMA PET scan. After the Fluciclovine PET/CT, the patient will follow up with their treating physician as per standard-of-care. The research team will collect clinical and imaging data at 6 months post Fluciclovine-PET/CT.
干预措施: Fluciclovine PET/CT (Drug)
结局指标
主要结局
Number of participants with BCR and a positive Fluciclovine PET performed within 30 days after a negative or equivocal PSMA PET
时间窗: During PET scan procedure
次要结局
- Correct localization rate (CLR) of Fluciclovine PET in patients with positive scans.(During PET scan procedure)
- Number of participants with positive Fluciclovine PET summarized by site of recurrence (local recurrence in the prostate bed, lymph node involvement, or distant metastatic disease), stratified by PSA level(During PET scan procedure)
- Change in management based on the results of Fluciclovine PET, relative to intended management based on the result of negative PSMA PET alone, prior to obtaining the Fluciclovine PET.(Enrollment up to 1 month after scan)
研究者
Nadine Mallak, MD
Principal Investigator
OHSU Knight Cancer Institute