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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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
Time frame: 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.
Time frame: 7 days after administration
To evaluate the proportion of subjects with a positive surgical margin (PSM) of ≥1 as assessed by histopathological examination after radical prostatectomy.
Time frame: 7 days after administration
Number of participants with Adverse events
Number of participants with Adverse events, with abnormal vital signs assessment, abnormal physical examination findings, abnormal electrocardiogram (ECG) readings, and abnormal laboratory tests including complete blood count (CBC), blood biochemistry, urine routine test, and coagulation function tests
Time frame: 7 days after administration
To evaluate the Tumor-to-Background Ratio (TBR)
Time frame: 7 days after administration
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