NCT07024030

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

A Clinical Phase I/II Study Evaluating the Safety, Tolerability and Pharmacokinetics of the PSMA-targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Haitao Niu, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer Patients Undergoing Radical Prostatectomy

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2024-10-30
• Primary completion: 2024-12-31
• Completion: 2025-03-31
• First posted: 2025-06-17
• Last updated: 2025-06-17

Locations

1 site across 1 country: China