18F-DCFPyL PET/CT in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer and Non-Contributory CT Scans
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 1
研究概览
简要总结
This study provides fluorine F 18 DCFPyL positron emission tomography/computed tomography (PET/CT) to participants with prostate cancer that has come back. Diagnostic procedures, such as fluorine F 18 DCFPyL PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate fluorine F 18 DCFPyL (18F-DCFPyL) PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated prostate-specific antigen (PSA).
OUTLINE:
Participants receive fluorine F 18 DCFPyL intravenously (IV). After 60-120 minutes, participants undergo whole body PET/CT. Immediately after the first scan, participants may undergo a second PET/CT without receiving fluorine F 18 DCFPyL.
After completion of study, participants are followed up at 24-72 hours.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven prostate adenocarcinoma
- •Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)
- •Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation
- •PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical prostatectomy
- •Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)
- •Post-radiation therapy - American Society for Radiation Oncology (ASTRO) - Phoenix consensus definition
- •A rise of PSA measurement of 2 or more ng/mL over the nadir
- •Able to provide written consent
- •Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group [ECOG] / World Health Organization [WHO] equivalent)
排除标准
- •Unable to provide informed consent
- •Inability to lie still for the entire imaging time
- •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 intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
研究者
Andrei Iagaru
Associate Professor of Radiology
Stanford University