Safety and Efficacy of PSMA-Targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Robot-Assisted Radical Prostatectomy

StatusCompleted
PhasePhase 2
SponsorZhu Yinjie
Started

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Record History

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  1. Primary endpoints: details revised at 1 of 2 entries Show 6 more changesShow less
    • Completed without a posted recruiting period
    • Primary completion date changed from estimate of Jun 30, 2026 to Aug 29, 2026
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 1, 2026 to Mar 20, 2026
    • Interventions: 0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery (Drug), 0.04 mg/kg of DGPR1008 Injection was administered 24… to 0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery (Drug), 0.04 mg/kg of DGPR1008 Injection was administered 24…
    • Eligibility criteria expanded, about 12 words
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07415135
Lead Sponsor Zhu Yinjie
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov