Safety and Efficacy Trial of a Targeted PSMA Fluorescent Contrast Agent (DGPR1008) for Intraoperative Imaging of Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer Patients Undergoing Radical Prostatectomy
• Interventions: Drug: 0.02mg/kg; Drug: 0.04mg/kg

• Registration Number: NCT07024030
• Lead Sponsor: Haitao Niu, MD

Brief Summary

a single-arm, open-label, multi-center study to evaluate safety, tolerability, pharmacokinetics, and the effectiveness of near-infrared fluorescence imaging during surgery.

Detailed Description

We plan to enroll 24 prostate cancer patients and divide them into 2 dosage groups. Intravenous administration will be conducted 24 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 Timeline

• Study Start: 2024-10-30
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31
• Study First Submitted: 2025-05-18
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-15
• Last Update Submitted: 2025-06-15
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Subjects must provide informed consent prior to enrollment, fully understand the trial details, adverse events, and communicate effectively with investigators. Written informed consent must be voluntarily signed.

Adult male subjects aged ≥18 years. Subjects with pathologically confirmed prostate cancer (Gleason score ≥7) via pre - operative prostate biopsy, scheduled for radical prostatectomy.

No significant liver or kidney impairment: liver - total bilirubin ≤2×ULN (except Gilbert syndrome), ALT/AST ≤3×ULN; kidney - creatinine clearance rate ≥50 mL/min/1.73m² (simplified MDRD).

No surgical contraindications; suitable for laparoscopic radical prostatectomy as determined by the investigator.

Subject and partner/spouse agree to avoid conception and sperm donation from screening until 3 months post - trial, and use effective contraception.

Exclusion Criteria

• Subjects will be excluded if any of the following apply:

Allergic constitution (history of allergy to ≥2 drugs), prone to allergic reactions, or allergic to the investigational drug (including components).

Clinically significant abnormal screening results affecting the study, or serious concomitant diseases (except stable cases approved by the investigator).

Participation in other clinical trials and received investigational products within 1 month before study drug administration.

Other conditions deemed unsuitable for enrollment by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
The first dose group	0.02mg/kg	Slowly infuse intravenously 24 hours before the scheduled surgery. 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 second dose group	0.04mg/kg	Slowly infuse intravenously 24 hours before the scheduled surgery. 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.

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of single-dose administration of DGPR1008 in patients	From the screening period to the day before withdrawal on Day 3 of the trial	Physical examination, with body mass index (BMI) reported as weight (kg)/height (m²), electrocardiogram (ECG) examination, and laboratory tests (blood routine, blood biochemistry, urinalysis, coagulation function).
To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients	PK blood samples will be collected 60 minutes before drug administration, and immediately, 30 minutes (±5 minutes), 1 hour (±10 minutes), 2 hours (±10 minutes), 4 hours (±20 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) after administration.	To measure the mean residence time (MRT₀-t, MRT₀-∞) of the drug in the blood of 24 subjects

Secondary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of the detection by DGPR1008 in conjunction with the near-infrared fluorescence imaging device for intraoperative imaging in patients.	24 hours before the surgery	Evaluate the sensitivity, specificity, false positive rate, false negative rate of DGPR1008 in detecting prostate cancer cells or tissues in near-infrared imaging, and assess the tumor-to-background ratio.

Trial Locations

Locations (1)

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China