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Completed

NCT Number: NCT07024030

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

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

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Key information

Conditions

Prostate Cancer Patients Undergoing Radical Prostatectomy

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266031, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: intravenous drip

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.

Other names: intravenous drip

Primary outcomes

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

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

    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.

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

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

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

    Time frame: 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 measure the maximum plasma concentration (Cmax) in the blood of 24 subjects

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

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

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

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

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

    Time frame: 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 measure the plasma elimination half-life (t₁/₂) in 24 subjects

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

    Time frame: 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 measure the blood clearance (CL) in 24 subjects

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

    Time frame: 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 measure the renal clearance (CL renal) in 24 subjects

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

    Time frame: 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 measure the terminal elimination rate constant (λz) in 24 subjects

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

    Time frame: 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 measure the apparent volume of distribution during terminal phase (Vz) in 24 subjects

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

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

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

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

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

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

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

    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).

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.

    Time frame: 24 hours before the surgery

    Evaluate the sensitivity, specificity, false positive rate, false negative rate of DGPR1008 in detecting prostate cancer cells or tissues in near-infrared imaging, and assess the tumor-to-background ratio.

Sponsors and collaborators

Lead sponsor

Haitao Niu, MD

Other

Registry information

Official study title

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

Acronym: DGPR1008

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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