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Safety and Efficacy Trial of a Targeted PSMA Fluorescent Contrast Agent (DGPR1008) for Intraoperative Imaging of Prostate Cancer | Clinical Trials | Clareo Health

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

A Clinical Phase I/II Study Evaluating the Safety, Tolerability and Pharmacokinetics of the PSMA-targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Prostate Cancer

NCT07024030•Haitao Niu, MD

View on ClinicalTrials.gov

Summary

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

Detailed Description

We plan to enroll 24 prostate cancer patients and divide them into 2 dosage groups. Intravenous administration will be conducted 24 hours before surgery. Blood samples will be collected for relevant tests, and fluorescence imaging will be performed during the operation. After surgery, the intraoperative imaging results will be compared with pathological findings to draw relevant conclusions.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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.

Locations (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Key Dates

Start Date

October 30, 2024

Primary Completion Date

December 31, 2024

Completion Date

March 31, 2025

Last Updated

June 17, 2025

Enrollment

ACTUAL participants

Conditions

Prostate Cancer Patients Undergoing Radical Prostatectomy

Interventions

0.02mg/kg

DRUG

0.04mg/kg

DRUG

Prehabilitation for Prostate Cancer Surgery

NCT02036684

Prostate Cancer Patients Undergoing Radical Prostatectomy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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