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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.02mg/kg DGPR1008 Injection Dose Group 1 (n=4~10) | Experimental | 0.02mg/kg |
|
| 0.04mg/kg DGPR1008 Injection Dose Group 1 (n=4~10) | Experimental | 0.04mg/kg |
|
| 0.06mg/kg DGPR1008 Injection Dose Group 1 (n=4~10) | Experimental | 0.06mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery | Drug | 0.02 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 7 days after administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Yin Zhu, medical doctor degree (MD) | Contact | +86 021-5875-2345 | yinjiezhu@outlook.com |
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| 0.04 mg/kg of DGPR1008 Injection was administered 24 hours before surgery | Drug | 0.04 mg/kg |
|
| 0.06 mg/kg of DGPR1008 Injection was administered 24 hours before surgery | Drug | 0.06 mg/kg |
|
| 7 days after administration |
| To evaluate the Tumor-to-Background Ratio (TBR) | 7 days after administration |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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