EUCTR2015-000625-37-GB进行中（未招募）1 期
A phase 3, open-label study to assess the clinical utility of fluciclovine (18F) PET/CT in patients with prostate cancer with biochemical recurrence after radical treatment - FALCON (Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of prostate cancer)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •(1) The subject is a male =18 years old.
- •(2) The subject has had an original diagnosis of PCa and underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR on the basis of:
- •a. Post RRT / brachytherapy: Increase in PSA level =2.0 ng/mL above the nadir level after radiotherapy (RT) or brachytherapy (ASTRO-Phoenix criteria) [53], or
- •b. Post RP: EITHER two consecutive rises in PSA and final PSA >0.1ng/ml OR three consecutive rises in PSA., This definition is also applicable to subjects with PSA persistence post RP (where the PSA fails to fall to undetectable levels).
- •i. In addition, the subject post RP, should have a PSA doubling time of =15 months OR PSA level =1.0 ng/mL at time of recruitment. The PSA doubling time will be calculated using the Memorial Sloan Kettering Cancer Center nomogram (http://www.mskcc.org/nomograms/prostate/psa-doubling-time), based on a minimum of two PSA levels within 12 months of screening, taken after the last recorded nadir PSA available at time of screening.
- •(3) The subject has not had previous recurrences of PCa, i.e. this is the first diagnosis of BCR.
- •(4) The subject is being considered for radical salvage therapy.
- •(5) The subject is able and willing to comply with study procedures, and signed, dated and timed informed consent is obtained before any study-related procedure is performed.
- •(6) The subject’s Eastern Cooperative Oncology Group [ECOG] performance status 0-2.
- •(7) The subject should not have received androgen-deprivation therapy within 3 months of screening.
- •(8) The subject has a normal or clinically acceptable medical history and vital signs findings at screening (up to 14 days before administration of study drug).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 135
排除标准
- •(1) The subject has been previously included in this study.
- •(2) The subject has received, or is scheduled to receive, another investigational medicinal product (IMP) from 1 month before to 1 week after administration of fluciclovine (18F) injection.
- •(3) The subject has known hypersensitivity to fluciclovine (18F) injection or any of its constituents.
- •(4) The subject has had a choline PET/CT scan within 3 months of the screening visit.
- •(5) The subject has bilateral hip prostheses.
研究者
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