First-in-human study of DGPR1008 for intraoperative fluorescence imaging of prostate-specific membrane antigen-positive prostate cancer in patients undergoing radical prostatectomy.

ABSTRACT:

Background

Prostate cancer (PCa) precise surgical resection remains a critical challenge due to positive margins compromising outcomes. This study sought to explore the safety and efficacy of DGPR1008, a novel near-infrared (NIR) prostate-specific membrane antigen (PSMA)-targeted fluorescent contrast agent, in fluorescence-guided surgery (FGS) of PCa.

Methods

This single-center, open-label, prospective, single-arm, exploratory study was carried out in The Fourth Affiliated Hospital of Soochow University, China. Patients newly diagnosed with PCa (a Gleason score ≥7) were eligible for enrollment. All patients underwent laparoscopic radical prostatectomy (LRP) with pelvic lymph node dissection (PLND) using DGPR1008. Four dose cohorts were studied: dose cohort A, which received

SUBMITTER: Li P 

PROVIDER: S-EPMC12541503 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature