NCT03739684已完成3 期
A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Clinical Impact of 18F-DCFPyL PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 14
- 主要终点
- Correct Localization Rate (CLR)
研究概览
简要总结
This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging in patients with suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.
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
- •Male >/= 18 years of age
- •Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy
- •Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of:
- •Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (American Urological Association [AUA]); or
- •Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (American Society for Therapeutic Radiology and Oncology [ASTRO]-Phoenix)
- •Negative or equivocal findings for prostate cancer on conventional imaging performed as part of standard of care workup within 60 days prior to Day 1
- •Life expectancy ≥6 months as determined by the investigator
- •Able and willing to provide informed consent and comply with protocol requirements
排除标准
- •Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives prior to Day 1
- •Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH agonist or antagonist) for prostate cancer
- •Treatment with ADT in the past 3 months of Day 1
- •Receipt of investigational therapy for prostate cancer within 60 days of Day 1
- •Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study
研究组 & 干预措施
18F-DCFPyL Injection
Experimental
9 mCi (333 MBq) IV injection of 18F-DCFPyL
干预措施: 18F-DCFPyL (Drug)
18F-DCFPyL Injection
Experimental
9 mCi (333 MBq) IV injection of 18F-DCFPyL
干预措施: PET/CT Imaging (Diagnostic Test)
结局指标
主要结局
Correct Localization Rate (CLR)
时间窗: Within 60 days following 18F-DCFPyL PET/CT imaging.
The Correct Localization Rate (CLR) will be defined as percentage of participants with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT imaging and the composite truth standard. Within 60 days following PyL PET/CT imaging, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the PyL-suspected lesion(s) will be performed.
次要结局
- Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results.(Pre 18F-DCFPyL PET/CT imaging and within 60 days following 18F-DCFPyL PET/CT imaging.)
- The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)(Measured at 2 intervals on the day of dosing; the first interval prior to receiving the 18F-DCFPyL dose and the second interval within 60 to 120 minutes after dosing.)
- The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure)(Measured at 2 intervals on the day of dosing; the first interval prior to receiving the 18F-DCFPyL dose and the second interval within 60 to 120 minutes after dosing.)
- Collection of Medical Procedures (Safety Outcome Measure)(From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.)
- Collection of Concomitant Medications (Safety Outcome Measure)(From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.)
研究者
研究点 (14)
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