The Impact of 18F Fluciclovine (FACBC) PET/CT (Positron Emission Computed Tomography) on Management of Patients With Rising PSA (Prostate-specific Antigen) After Initial Prostate Cancer Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 17
- 主要终点
- The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.
研究概览
简要总结
This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.
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
- •History of histologically confirmed adenocarcinoma of the prostate post curative-intent local treatment (radical prostatectomy, local radiotherapy, brachytherapy).
- •Suspicion of recurrent prostate carcinoma after previous presumed definitive therapy for organ confined disease defined as :
- •Post prostatectomy: Detectable or rising PSA level that is >0.2 ng/mL with a second confirmatory level of >0.2 ng/mL
- •Post non-prostatectomy: PSA rise ≥ 2ng/mL over nadir
- •Negative or equivocal findings on standard-of-care imaging for restaging of disease in the previous 60 days consisting of: Whole-body 99mTc bone scintigraphy or NaF PET-CT; and either CT or MRI of the pelvis (or the abdomen and pelvis).
- •Being considered for salvage therapy
- •Any non-surgical local treatment such as previous cryotherapy, external beam radiation, or HiFU (Ultrasound) must have occurred at least 1 year in the past.
- •Previous brachytherapy treatment will have occurred at least 2 years in the past
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist)
- •Androgen deprivation therapy (ADT) in the past 3 months
- •History of bilateral orchidectomy
- •Inability to tolerate 18F-fluciclovine PET/CT
研究组 & 干预措施
18F-fluciclovine PET CT
Single intravenous administration of 18F-fluciclovine PET CT.
干预措施: 18F-fluciclovine PET CT (Drug)
结局指标
主要结局
The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.
时间窗: 2-22 days post PET CT
The change of management will be based on referring physician questionnaires completed pre- and post- 18F-fluciclovine PET/CT
次要结局
- The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment(6 months)
- The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population(1 week)
- The Rate of Detection of Disease in 1) Prostate and Prostate Bed and 2) Extra-prostatic Regions With 18F-fluciclovine PET/CT in the Study Population(1 week)
- The Positive Predictive Value (PPV) of 18F-fluciclovine PET/CT for Regional Disease Compared to Biopsy in Those Patients Who Undergo Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy(6 months)
- The PPV of 18F-fluciclovine PET/CT for Distant Disease Compared to Biopsy in Those Patients Who Undergo a Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy(6 months)