NCT03768349已完成早期 1 期
PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Tumor Detection on PET/CT
研究概览
简要总结
Imaging and staging of prostate cancer is critical for surgical and treatment planning. In this protocol we will image patients with suspected metastatic prostate cancer using 11C-Choline PET and Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or F-18 labeled PSMA 1007 in order to demonstrate their utility in detecting prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histopathological proven prostate adenocarcinoma.
- •Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
- •a. Post radical prostatectomy (RP) - with or without radiation. i. PSA greater than or equal to 0.2 ng/mL measured more than 12 weeks after RP. ii. > 3 months post-surgery b. Post-radiation therapy ASTRO-Phoenix consensus definition c. May or may not be castrate resistant (list prior therapies)
- •Karnofsky performance status of 50 (or ECOG/WHO equivalent).
- •CT or as part of the PET study or performed within one month of PSMA PET.
- •Ability to understand a written informed consent document, and the willingness to sign it.
排除标准
- •Undergoing investigational therapy for prostate cancer.
- •Other ongoing treatments for prostate cancer including radiation therapy, chemotherapy or androgen deprivation. Androgen deprivation within the last 4 months excluding finasteride, dutasteride or other 5 alpha reductase inhibitors (excluding castrate resistant subjects).
- •Unable to lie flat, still or tolerate a PET scan.
- •Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
- •Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
- •Absence of PSA and total testosterone tests within 4 weeks.
研究组 & 干预措施
PET/CT Ga-68 PSMA
Experimental
Ga-68 labeled PSMA-11 (or PSMA-HBED-CC) PET/CT
干预措施: Ga-68 PSMA11 (Drug)
PET/CT F-18 Labeled PSMA 1007
Experimental
F-18 Labeled PSMA 1007 PET/CT
干预措施: F-18 PSMA 1007 (Drug)
结局指标
主要结局
Tumor Detection on PET/CT
时间窗: 12 Months post PET/CT
Positive predictive value on a per-patient and per-region-basis of PSMA and C-11 choline PET/CT for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up.
次要结局
- Incidence of adverse events attributable to PSMA(12 Months)
- Impact of PSMA and C-11 choline PET on clinical management(12 Months)
研究者
研究点 (1)
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