PSMA-Targeted Intraoperative Fluorescent Imaging Agents (... | NCT07387510

NCT07387510

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1	Experimental	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.	Drug: 12 h before RP
group 2	Experimental	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.	Drug: 24 h before RP
group 3	Experimental	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.	Drug: 36 h before RP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
12 h before RP	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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.

Secondary Outcomes

Measure	Description	Time Frame
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.	From the screening period to the Day 7 of the trial

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects diagnosed with prostate cancer through preoperative transrectal prostate biopsy and pathological examination, who are scheduled to undergo radical prostatectomy with or without pelvic lymph node dissection;
Subjects must provide informed consent prior to trial initiation, fully understand the trial content, procedures, and potential adverse reactions, be capable of effective communication with the investigator, and be able to complete the trial as per protocol requirements. They must voluntarily sign a written informed consent form;
Adult male subjects aged 18 years or older (including the boundary value);
Gleason score ≥7, or imaging studies (transrectal ultrasound [TRUS] and/or prostate magnetic resonance imaging [MRI] or CT or PSMA PET/CT) demonstrating disease staging ≥T2, or imaging evidence of regional lymph node enlargement suggestive of lymph node metastasis;
No hepatic or renal impairment: Hepatic: Total bilirubin ≤ 2 times the upper limit of normal (ULN) (excluding Gilbert syndrome), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3×ULN; Renal: Creatinine clearance ≥ 50 mL/min/1.73 m² (simplified MDRD formula);
The investigator determines the subject has no clear contraindications for surgery and is suitable for radical prostatectomy;
The subject and their partner or spouse must agree to have no plans for pregnancy or sperm donation from the screening period until 3 months after trial completion, and voluntarily use effective contraception.

Exclusion Criteria:

Subjects will be excluded if they meet any one of the following criteria:

Subjects with a history of allergies (e.g., known allergies to two or more medications), those prone to allergic reactions such as rashes or hives, or those with known allergies to the investigational drug (including its formulation components);
Subjects with significantly abnormal screening test results deemed clinically significant by the investigator and likely to affect study participation; or those with concomitant conditions posing serious safety risks or impeding study completion (except where the investigator determines the condition is stable and allows enrollment);
Subjects who participated in another clinical trial involving investigational drugs or devices within the month preceding study drug administration;
Subjects who have undergone neoadjuvant therapy, radiation therapy, focal ablation therapy, hormone therapy, or androgen deprivation therapy within the past 6 months;
Subjects deemed by the investigator to have other conditions rendering them unsuitable for participation in this trial.

Name	Role	Phone	Extension	Email
Haitao Niu	Contact	86+0532-82911329		niuht0532@126.com
Xuecheng Yang	Contact	86+18516509790		m18661805062@163.com