CompletedPhase 2

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

China24 participantsStarted 2024-10-30

Plain-language summary

a single-arm, open-label, multi-center study to evaluate safety, tolerability, pharmacokinetics, and the effectiveness of near-infrared fluorescence imaging during surgery.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

1

To evaluate the safety of single-dose administration of DGPR1008 in patients

Timeframe: From the screening period to the day before withdrawal on Day 3 of the trial

2

To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients

Timeframe: PK blood samples will be collected 60 minutes before drug administration, and immediately, 30 minutes (±5 minutes), 1 hour (±10 minutes), 2 hours (±10 minutes), 4 hours (±20 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) after administration.

3

To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients

Timeframe: PK blood samples will be collected 60 minutes before drug administration, and immediately, 30 minutes (±5 minutes), 1 hour (±10 minutes), 2 hours (±10 minutes), 4 hours (±20 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) after administration.

4

To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients

Timeframe: PK blood samples will be collected 60 minutes before drug administration, and immediately, 30 minutes (±5 minutes), 1 hour (±10 minutes), 2 hours (±10 minutes), 4 hours (±20 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) after administration.

5

To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients

Timeframe: PK blood samples will be collected 60 minutes before drug administration, and immediately, 30 minutes (±5 minutes), 1 hour (±10 minutes), 2 hours (±10 minutes), 4 hours (±20 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) after administration.

Trial details

NCT IDNCT07024030

SponsorHaitao Niu, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31