NCT07115277招募中不适用
A Single-arm, Multicenter, Phase III Clinical Trial , Evaluate the Diagnostic Performance and Safety of Flotufolastat F-18 Injection PET Imaging in Prostate Cancer Subjects With Biochemical Recurrence Following Prior Treatment
Sinotau Pharmaceutical Group1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2025年3月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- To evaluate the diagnostic performance of Flotufolastat F-18 Injection PET imaging in Chinese prostate cancer subjects with biochemical recurrence (BCR)
研究概览
简要总结
The goal of this clinical trial is to evaluate the diagnostic performance and safety of Flotufolastat F-18 injection PET imaging in prostate cancer subjects with biochemical recurrence following prior treatment. The main question it aims to answer is:
• What is the correct detection rate of Flotufolastat F 18 injection PET visual reading results compared to the truth standard?
Participants will:
- Receive Flotufolastat F-18 injection
- Undergo PET/CT scanning
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
- •Fully understand the study and voluntarily sign the informed consent form.
- •Male, aged ≥18 years.
- •Has previously received one or more of the following treatments:
- •Radical prostatectomy (RP);
- •RP with adjuvant radiotherapy (RT);
- •RP with adjuvant androgen deprivation therapy (ADT);
- •Radical RT or focal gland therapy (e.g., brachytherapy, high-intensity focused ultrasound [HIFU]).
- •Clinically suspected BCR, serum PSA levels should meet at least one of the followings:
- •After RP with or without adjuvant or salvage therapy: PSA≥ 0.2 ng/mL, and subsequent confirmation that PSA ≥ 0.2 ng/mL.
- •After RT as primary treatment: PSA increased at least 2 ng/mL compaire to the nadir.
- •After focal gland therapy as primary treatment: PSA increased at least 2 ng/mL compaire to the nadir.
- •If positive lesions are detected on the XTR020 PET imaging or conventional imaging, the subject is willing to receive histopathological confirmation or the sequqnce of conventional imaging confirmation.
- •Male subjects with reproductive potential must use effective contraception during the study period and 6 months after the study completed; their partners should agree to use contraception during the study period and 6 months after the study completed , too.
排除标准
- •Planned to receive an X-ray contrast agent or other radioactive imaging agent within 24 hours before XTR020 PET imaging.
- •Participation in an interventional clinical trial involving a new drug or treatment within 30 days or 5 biological half-lives of the drug prior to XTR020 PET imaging (whichever is longer).
- •Known allergy to the active ingredient or any excipient of XTR
- •Claustrophobia or inability to tolerate imaging examinations for any other reason.
- •Poor compliance or deemed unsuitable for participation in this study by the investigator.
- •Any condition that, in the opinion of the investigator, may interfere with data collection or prevent the study requirements.
研究组 & 干预措施
All prostate cancer subjects will undergo PET imaging using Flotufolastat F-18 Injection
Experimental
干预措施: Flotufolastat F-18 Injection (Drug)
结局指标
主要结局
To evaluate the diagnostic performance of Flotufolastat F-18 Injection PET imaging in Chinese prostate cancer subjects with biochemical recurrence (BCR)
时间窗: 90 days
Correct Detection Rate (CDR) at the individual level of Flotufolastat F-18 Injection PET imaging in prostate cancer subjects with BCR
次要结局
- To evaluate the diagnostic performance of Flotufolastat F-18 Injection PET imaging in different subgroups of Chinese prostate cancer subjects with BCR(90 days)
- To evaluate inter-reader and intra-reader interpretative consistency among independent blinded readers.(90 days)
- To evaluate other diagnostic performance parameters of Flotufolastat F-18 Injection PET imaging in Chinese prostate cancer subjects with BCR(90 days)
- To evaluate the safety of Flotufolastat F-18 Injection .(3 days)
研究者
研究点 (1)
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