NCT07415135尚未招募2 期
Phase Ⅱ Clinical Study on the Safety and Efficacy of PSMA-Targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Robot-Assisted Radical Prostatectomy
Zhu Yinjie0 个研究点目标入组 18 人开始时间: 2026年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 主要终点
- To evaluate the sensitivity (true positive rate, TP/(TP+FN)), specificity (true negative rate, TN/(TN+FP)), false positive rate (FP/(FP+TN)) and false negative rate (FN/(FN+TP)) of DGPR1008 for detecting prostate cancer tissues via near-infrared fluoresc
研究概览
简要总结
This study is a single-center, single-arm, open-label exploratory study to evaluate the safety and efficacy of fluorescent imaging combined with a robotic surgical control system for robot-assisted radical prostatectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Subjects with pathologically confirmed prostate cancer via preoperative prostate core needle biopsy who are scheduled to undergo robot-assisted radical prostatectomy (RARP).
- •Subjects must provide informed consent for the trial prior to enrollment, with a full understanding of the trial content, procedures and potential adverse events; they must be able to communicate effectively with investigators, comply with the trial protocol to complete the entire study, and voluntarily sign a written informed consent form.
- •Male adult subjects aged 18 years or older (inclusive).
- •Gleason total score ≥7, or radiological findings (transrectal ultrasound (TRUS) and/or prostate magnetic resonance imaging (MRI), computed tomography (CT) or prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT)) indicating clinical stage ≥T
- •No hepatic or renal impairment: Hepatic function: Total bilirubin ≤2 × upper limit of normal (ULN) (except for Gilbert's syndrome), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3 × ULN; Renal function: Creatinine clearance rate ≥50 mL/min/1.73 m² (calculated via the simplified MDRD equation).
- •Subjects judged by the investigator to have no definite surgical contraindications and to be suitable for robot-assisted radical prostatectomy (RARP).
- •Subjects and their partners/spouses must agree to have no childbearing or sperm donation plans from the screening period to 3 months after the trial completion, and voluntarily adopt effective contraceptive measures.
排除标准
- •Subjects with an allergic diathesis (e.g., a known history of hypersensitivity to two or more drugs), a predisposition to allergic symptoms such as rashes or urticaria, or a known hypersensitivity to the study drug (including its ingredients).
- •Subjects with clinically significant abnormal findings in screening tests that are judged by the investigator to affect the study; or those with comorbidities that pose a serious risk to subject safety or interfere with study completion (except for subjects whose conditions are judged by the investigator to be stable for enrollment).
- •Subjects who have participated in other clinical trials and received investigational drugs or medical devices within 1 month prior to the administration of the study drug.
- •Subjects who have received neoadjuvant therapy, radiotherapy, focal ablation therapy, hormonal therapy, androgen deprivation therapy, or other such treatments in the past 6 months.
- •Subjects who are judged by the investigator to be ineligible for the study due to other circumstances.
研究组 & 干预措施
0.02mg/kg DGPR1008 Injection Dose Group 1 (n=4~10)
Experimental
0.02mg/kg
干预措施: 0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery (Drug)
0.04mg/kg DGPR1008 Injection Dose Group 1 (n=4~10)
Experimental
0.04mg/kg
干预措施: 0.04 mg/kg of DGPR1008 Injection was administered 24 hours before surgery (Drug)
0.06mg/kg DGPR1008 Injection Dose Group 1 (n=4~10)
Experimental
0.06mg/kg
干预措施: 0.06 mg/kg of DGPR1008 Injection was administered 24 hours before surgery (Drug)
结局指标
主要结局
To evaluate the sensitivity (true positive rate, TP/(TP+FN)), specificity (true negative rate, TN/(TN+FP)), false positive rate (FP/(FP+TN)) and false negative rate (FN/(FN+TP)) of DGPR1008 for detecting prostate cancer tissues via near-infrared fluoresc
时间窗: 7 days after administration
To evaluate the proportion of additionally resected tissues (due to fluorescent signals in tumor beds identified by near-infrared fluorescent imaging (NIR)) that are assessed as tumor-positive by histopathological examination after radical prostatectomy.
时间窗: 7 days after administration
次要结局
- To evaluate the proportion of subjects with a positive surgical margin (PSM) of ≥1 as assessed by histopathological examination after radical prostatectomy.(7 days after administration)
- Number of participants with Adverse events(7 days after administration)
- To evaluate the Tumor-to-Background Ratio (TBR)(7 days after administration)
研究者
Zhu Yinjie
Clinical Professor
RenJi Hospital
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