prostate cancer
Conditions
Interventions
Dose group 1:Intravenous infusion of 0.02mg/kg at 24 hours (+/-4 hours) before surgery
Dose group 2:Intravenous infusion of 0.04mg/kg at 24 hours (+/-4 hours) before surgery
Sponsors
The First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects with prostate cancer confirmed by pathological diagnosis through preoperative prostate biopsy, and scheduled to undergo Robot-Assisted Radical Prostatectomy (RARP) and Extended Pelvic Lymph Node Dissection (ePLND); 2. Subjects must have been informed of and consented to the trial before participation, fully understand the trial content, process and possible adverse reactions, be able to communicate well with researchers, complete the trial in accordance with the protocol, and voluntarily sign a written informed consent form; 3. Male subjects aged 18 years or older (inclusive of the boundary value); 4. Gleason total score >= 8, or subjects with imaging findings (transrectal ultrasound (TRUS) and/or prostate magnetic resonance imaging (MRI), or CT, or PSMA PET/CT) showing disease stage >= T2c, or imaging showing suspicious regional lymph node enlargement indicating lymph node metastasis; 5. No liver or kidney impairment: For the liver: total bilirubin = 2 × upper limit of normal (ULN) (except for Gilbert's syndrome), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 3 × ULN; For the kidney: creatinine clearance = 50 mL/min/1.73 m² (calculated by the simplified MDRD formula); 6. Subjects are judged by researchers to have no definite surgical contraindications and are suitable for robot-assisted radical prostatectomy; 7. Subjects and their partners or spouses must agree to have no fertility plans or sperm donation plans from the screening period to 3 months after the end of the trial, and voluntarily adopt effective contraceptive mea
Exclusion criteria
Exclusion criteria: 1. Subjects with allergic constitution (e.g., those with a known history of allergies to two or more drugs), or those prone to allergic symptoms such as rashes and urticaria, or those with known allergies to the trial drug (including its components); 2. Subjects with significantly abnormal screening test results that are clinically significant and may affect the study as judged by the researcher; or those with concomitant diseases that seriously endanger the subject's safety or affect the completion of the study (except for subjects whose condition is stable and deemed eligible for enrollment by the researcher); 3. Subjects who participated in other clinical trials and received trial drugs or devices within 1 month before using the study drug; 4. Subjects who received neoadjuvant therapy, radiotherapy, focal ablation therapy, hormone therapy, or androgen deprivation therapy, etc., within the past 6 months; 5. Subjects who, in the researcher's judgment, have other conditions that make them unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the proportion of histopathologically confirmed positive tumors in the additionally resected tissues that are identified as visible by near-infrared fluorescence imaging (NIR) in the tumor bed after radical prostatectomy.;Evaluate the coincidence rate between near-infrared fluorescently visualized lymph nodes and histopathologically positive lymph nodes.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, vital signs examination, physical examination, electrocardiogram examination, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function);;Evaluate the proportion of subjects with histopathologically assessed positive surgical margins (PSM) >= 1;;Evaluate the sensitivity (or true positive rate, TP/(TP+FN)) of DGPR1008 in detecting prostate cancer cells or tissues in near-infrared fluorescence imaging;;Evaluate the specificity (or true negative rate, TN/(TN+FP)) of DGPR1008 in detecting prostate cancer cells or tissues in near-infrared fluorescence imaging;;Evaluate the false positive rate (FP/(FP+TN)) of DGPR1008 in detecting prostate cancer cells or tissues in near-infrared fluorescence imaging;;Evaluate the false negative rate (FN/(FN+TP)) of DGPR1008 in detecting prostate cancer cells or tissues in near-infrared fluorescence imaging;; | — |
Countries
China
Contacts
Public ContactXu Zhang
The First Medical Center of Chinese PLA General Hospital
Outcome results
None listed