Safety and Efficacy of PSMA-Targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Robot-Assisted Radical Prostatectomy
NCT07415135 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-02-17
Summary
This study is a single-center, single-arm, open-label exploratory study to evaluate the safety and efficacy of fluorescent imaging combined with a robotic surgical control system for robot-assisted radical prostatectomy.
Conditions
Interventions
- DRUG
-
0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery
0.02 mg/kg
- DRUG
-
0.04 mg/kg of DGPR1008 Injection was administered 24 hours before surgery
0.04 mg/kg
- DRUG
-
0.06 mg/kg of DGPR1008 Injection was administered 24 hours before surgery
0.06 mg/kg
Sponsors & Collaborators
-
Zhu Yinjie
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-01
- Primary Completion
- 2026-06-30
- Completion
- 2026-12-31
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