a Phase II, single-arm, open-label, multi-center study to evaluate safety, tolerability, pharmacokinetics, and the effectiveness of near-infrared fluorescence imaging during surgery.
We plan to enroll 27 prostate cancer patients and divide them into 3 different time-window groups. Intravenous administration will be conducted 12/24/36 hours before surgery. Blood samples will be collected for relevant tests, and fluorescence imaging will be performed during the operation. After surgery, the intraoperative imaging results will be compared with pathological findings to draw relevant conclusions.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
DGPR1008 (0.04 mg/kg according to each subject's body weight) was given as a single slow infusion 12 hours (±4 hours) preoperatively, after which radical prostatectomy was performed. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field.
DGPR1008 (0.04 mg/kg according to each subject's body weight) was given as a single slow infusion 24 hours (±4 hours) preoperatively, after which radical prostatectomy was performed. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field.
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Evaluate the efficacy of DGPR-1008 (administered 12 hours prior) in conjunction with a near-infrared fluorescence imaging device for intraoperative detection in patients.
Detection of prostate cancer tissue by DGPR1008 using near-infrared fluorescence (NIR) imaging at 12 hours after intravenous administration to subjects. Evaluate the sensitivity (or true positive rate, TP/\[TP+FN\]), specificity (or true negative rate, TN/\[TN+FP\]), false positive rate (FP/\[FP+TN\]), and false negative rate (FN/\[FN+TP\]) of DGPR-1008 for detecting prostate cancer tissue in near-infrared fluorescence imaging (NIR) during radical prostatectomy. The proportion of additionally resected tissues that are diagnosed as tumors by pathological evaluation.
Time frame: From the screening period to the Day 7 of the trial
Evaluate the efficacy of DGPR-1008 (administered 24 hours prior) in conjunction with a near-infrared fluorescence imaging device for intraoperative detection in patients.
Detection of prostate cancer tissue by DGPR1008 using near-infrared fluorescence (NIR) imaging at 24 hours after intravenous administration to subjects. Evaluate the sensitivity (or true positive rate, TP/\[TP+FN\]), specificity (or true negative rate, TN/\[TN+FP\]), false positive rate (FP/\[FP+TN\]), and false negative rate (FN/\[FN+TP\]) of DGPR-1008 for detecting prostate cancer tissue in near-infrared fluorescence imaging (NIR) during radical prostatectomy. The proportion of additionally resected tissues that are diagnosed as tumors by pathological evaluation.
Time frame: From the screening period to the Day 7 of the trial
Evaluate the efficacy of DGPR-1008 (administered 36 hours prior) in conjunction with a near-infrared fluorescence imaging device for intraoperative detection in patients.
Detection of prostate cancer tissue by DGPR1008 using near-infrared fluorescence (NIR) imaging at 36 hours after intravenous administration to subjects. Evaluate the sensitivity (or true positive rate, TP/\[TP+FN\]), specificity (or true negative rate, TN/\[TN+FP\]), false positive rate (FP/\[FP+TN\]), and false negative rate (FN/\[FN+TP\]) of DGPR-1008 for detecting prostate cancer tissue in near-infrared fluorescence imaging (NIR) during radical prostatectomy. The proportion of additionally resected tissues that are diagnosed as tumors by pathological evaluation.
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DGPR1008 (0.04 mg/kg according to each subject's body weight) was given as a single slow infusion 36 hours (±4 hours) preoperatively, after which radical prostatectomy was performed. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field.
Time frame: From the screening period to the Day 7 of the trial
Evaluate DGPR1008 combined with near-infrared fluorescence imaging devices for detecting positive margins in histopathological examination following radical prostatectomy
To evaluate the proportion of subjects with a positive surgical margin (PSM) score of ≥1, as assessed by histopathology, at different time points after radical prostatectomy.
Time frame: From the screening period to the Day 7 of the trial
Evaluate DGPR1008 combined with near-infrared fluorescence imaging devices for detecting positive lymph nodes in histopathological examination following radical prostatectomy
To evaluate the proportion of subjects with positive lymph nodes, as assessed by histopathology, at different time points after radical prostatectomy.
Time frame: From the screening period to the Day 7 of the trial
Evaluate the safety of single-dose administration of DGPR1008 in patients
Adverse event collection, including (such as the location, nature, and frequency of pain), physical signs (such as the scope of rash, blood pressure values), laboratory abnormal values and units (such as ALT 200 U/L), etc.
Time frame: From the screening period to the Day 7 of the trial