NCT07387510

PSMA-Targeted Intraoperative Fluorescent Imaging Agents (DGPR1008): Validation Across Different Time Windows

A Phase Ⅱ, Single-arm, Open-label Trial of DGPR1008 for Intraoperative Fluorescence Imaging of Prostate-specific Membrane Antigen-positive Prostate Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Haitao Niu, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer Patients Undergoing Radical Prostatectomy

Interventions

Type	Name	Description
DRUG	12 h before RP	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	24 h before RP	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	36 h before RP	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.

Timeline

• Start date: 2026-02-27
• Primary completion: 2026-07-27
• Completion: 2026-09-27
• First posted: 2026-02-04
• Last updated: 2026-02-04

Locations

1 site across 1 country: China