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

Prior treatment

• Subjects will be excluded if any of the following apply:
  • Allergic constitution (history of allergy to ≥2 drugs), prone to allergic reactions, or allergic to the investigational drug (including components).
  • Clinically significant abnormal screening results affecting the study, or serious concomitant diseases (except stable cases approved by the investigator).
  • Participation in other clinical trials and received investigational products within 1 month before study drug administration.
  • Other conditions deemed unsuitable for enrollment by the investigator.

• Subjects must provide informed consent prior to enrollment, fully understand the trial details, adverse events, and communicate effectively with investigators. Written informed consent must be voluntarily signed.
  • Adult male subjects aged ≥18 years. Subjects with pathologically confirmed prostate cancer (Gleason score ≥7) via pre - operative prostate biopsy, scheduled for radical prostatectomy.
  • No significant liver or kidney impairment: liver - total bilirubin ≤2×ULN (except Gilbert syndrome), ALT/AST ≤3×ULN; kidney - creatinine clearance rate ≥50 mL/min/1.73m² (simplified MDRD).
  • No surgical contraindications; suitable for laparoscopic radical prostatectomy as determined by the investigator.
  • Subject and partner/spouse agree to avoid conception and sperm donation from screening until 3 months post - trial, and use effective contraception.