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

NCT07024030 | Completed Phase 2

• 2 other identifiers: QYFYEC2024-047-04CXHL2400243
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer Patients Undergoing Radical Prostatectomy

Keywords

DGPR1008

Outcome Measures

Primary Outcomes (13)

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

  Adverse event collection, including (such as the location, nature, and frequency of pain), physical signs (such as the scope of rash, blood pressure values), laboratory abnormal values and units (such as ALT 200 U/L), etc.

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

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

  To measure the area under the plasma concentration-time curve from time 0 to infinity (AUC₀-∞) in the blood of 24 subjects

  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.

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

  To measure the maximum plasma concentration (Cmax) in the blood of 24 subjects

  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.

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

  To measure the area under the plasma concentration-time curve from time 0 to time t (AUC₀-t) in the blood of 24 subjects

  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.

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

  To measure the percentage of extrapolated area under the plasma concentration-time curve (AUC%Extrap) in the blood of 24 subjects

  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.

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

  To measure the plasma elimination half-life (t₁/₂) in 24 subjects

  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.

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

  To measure the blood clearance (CL) in 24 subjects

  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.

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

  To measure the renal clearance (CL renal) in 24 subjects

  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.

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

  To measure the terminal elimination rate constant (λz) in 24 subjects

  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.

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

  To measure the apparent volume of distribution during terminal phase (Vz) in 24 subjects

  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.

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

  Vital signs examination, such as blood pressure, oxygen saturation, pulse and other data.

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

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

  To measure the mean residence time (MRT₀-t, MRT₀-∞) of the drug in the blood of 24 subjects

  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.

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

  Physical examination, with body mass index (BMI) reported as weight (kg)/height (m²), electrocardiogram (ECG) examination, and laboratory tests (blood routine, blood biochemistry, urinalysis, coagulation function).

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

Secondary Outcomes (1)

• Evaluate the effectiveness of the detection by DGPR1008 in conjunction with the near-infrared fluorescence imaging device for intraoperative imaging in patients.

  24 hours before the surgery

Study Arms (2)

The first dose group

EXPERIMENTAL

Slowly infuse intravenously 24 hours before the scheduled surgery. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field.

Drug: 0.02mg/kg

The second dose group

EXPERIMENTAL

Slowly infuse intravenously 24 hours before the scheduled surgery. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field.

Drug: 0.04mg/kg

Interventions

0.02mg/kg DRUG

Slowly infuse intravenously 24 hours before the scheduled surgery. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field.

Also known as: intravenous drip

The first dose group

0.04mg/kg DRUG

Slowly infuse intravenously 24 hours before the scheduled surgery. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field.

Also known as: intravenous drip

The second dose group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haitao Niu, MD: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266031, China

Location

MeSH Terms

Interventions

Infusions, Intravenous

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Member of the Standing Committee of the Party Committee, Vice President of Qingdao University,

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: June 17, 2025
• Study Start: October 30, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

CN (1)