NCT07649122招募中3 期
A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Safety of 68Ga-NYM032 Injection PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- PPV
研究概览
简要总结
This study evaluates the diagnostic performance and safety of 68Ga-NYM032 PET/CT imaging in patients with suspected recurrence of prostate cancer.
详细描述
Imaging and staging of prostate cancer is critical for surgical and treatment planning. Prostate-specific membrane antigen (PSMA) is a transmembrane surface protein highly overexpressed in over 90% of prostate cancer lesions. Patients with suspected metastatic prostate cancer will undergo imaging with ⁶⁸Ga NYM032 Injection, a PSMA targeted radiotracer.
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
- •Patient is male and aged >18 years old.
- •Participants with histopathologically confirmed prostate adenocarcinoma, who present with elevated PSA and suspected recurrence following radical prostatectomy and/or radiotherapy and/or other radical prostate cancer treatments (e.g., proton therapy, cryoablation, high-intensity focused ultrasound, etc.). (PSA must be measured within 30 days prior to screening.). (Meeting any one of the following criteria):
- •Post-radical prostatectomy (RP): PSA ≥0.2 ng/mL on two consecutive measurements obtained ≥6 weeks after surgery;
- •Post-radiotherapy (as defined by the ASTRO-Phoenix consensus): PSA rise ≥2 ng/mL above the PSA nadir;
- •Participants with recurrence after other treatments: PSA rise ≥2 ng/mL above the PSA nadir.
- •ECOG performance status 0-2; expected survival ≥ 6 months.
- •Ability to understand a written informed consent document, and the willingness to sign it.
排除标准
- •Participants who have previously participated in other interventional clinical trials and are within five physical half-lives, or have received radionuclide agents previously with an interval of less than ten physical half-lives prior to study drug injection.
- •Participants administered any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection.
- •Known hypersensitivity to the active ingredient or excipients of the study drug.
- •Participants not capable of getting PET study , or inability to lay still for the duration of the exam.
- •Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.
研究组 & 干预措施
68-Ga-NYM032
Experimental
干预措施: 68-Ga-NYM032 (Diagnostic Test)
结局指标
主要结局
PPV
时间窗: up to12 months
Positive predictive value (PPV)were calculated on a per-patient basis on 68Ga-NYM032 PET/CT for detection of tumor location confirmed by the composite truth standard.
次要结局
未报告次要终点
研究者
研究点 (2)
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