Safety and Efficacy of PSMA-Targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Robot-Assisted Radical Prostatectomy

NCT07415135 | Not Yet Recruiting Phase 2

• 1 other identifier: Zhu Yinjie
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a single-center, single-arm, open-label exploratory study to evaluate the safety and efficacy of fluorescent imaging combined with a robotic surgical control system for robot-assisted radical prostatectomy.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• To evaluate the sensitivity (true positive rate, TP/(TP+FN)), specificity (true negative rate, TN/(TN+FP)), false positive rate (FP/(FP+TN)) and false negative rate (FN/(FN+TP)) of DGPR1008 for detecting prostate cancer tissues via near-infrared fluoresc

  7 days after administration

• To evaluate the proportion of additionally resected tissues (due to fluorescent signals in tumor beds identified by near-infrared fluorescent imaging (NIR)) that are assessed as tumor-positive by histopathological examination after radical prostatectomy.

  7 days after administration

Secondary Outcomes (3)

• To evaluate the proportion of subjects with a positive surgical margin (PSM) of ≥1 as assessed by histopathological examination after radical prostatectomy.

  7 days after administration

• Number of participants with Adverse events

  7 days after administration

• To evaluate the Tumor-to-Background Ratio (TBR)

  7 days after administration

Study Arms (3)

0.02mg/kg DGPR1008 Injection Dose Group 1 (n=4~10)

EXPERIMENTAL

0.02mg/kg

Drug: 0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery

0.04mg/kg DGPR1008 Injection Dose Group 1 (n=4~10)

EXPERIMENTAL

0.04mg/kg

Drug: 0.04 mg/kg of DGPR1008 Injection was administered 24 hours before surgery

0.06mg/kg DGPR1008 Injection Dose Group 1 (n=4~10)

EXPERIMENTAL

0.06mg/kg

Drug: 0.06 mg/kg of DGPR1008 Injection was administered 24 hours before surgery

Interventions

0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery DRUG

0.02 mg/kg

0.02mg/kg DGPR1008 Injection Dose Group 1 (n=4~10)

0.04 mg/kg of DGPR1008 Injection was administered 24 hours before surgery DRUG

0.04 mg/kg

0.04mg/kg DGPR1008 Injection Dose Group 1 (n=4~10)

0.06 mg/kg of DGPR1008 Injection was administered 24 hours before surgery DRUG

0.06 mg/kg

0.06mg/kg DGPR1008 Injection Dose Group 1 (n=4~10)

Eligibility Criteria

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

You may qualify if:

• Subjects with pathologically confirmed prostate cancer via preoperative prostate core needle biopsy who are scheduled to undergo robot-assisted radical prostatectomy (RARP).
• Subjects must provide informed consent for the trial prior to enrollment, with a full understanding of the trial content, procedures and potential adverse events; they must be able to communicate effectively with investigators, comply with the trial protocol to complete the entire study, and voluntarily sign a written informed consent form.
• Male adult subjects aged 18 years or older (inclusive).
• Gleason total score ≥7, or radiological findings (transrectal ultrasound (TRUS) and/or prostate magnetic resonance imaging (MRI), computed tomography (CT) or prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT)) indicating clinical stage ≥T2.
• No hepatic or renal impairment: Hepatic function: Total bilirubin ≤2 × upper limit of normal (ULN) (except for Gilbert's syndrome), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3 × ULN; Renal function: Creatinine clearance rate ≥50 mL/min/1.73 m² (calculated via the simplified MDRD equation).
• Subjects judged by the investigator to have no definite surgical contraindications and to be suitable for robot-assisted radical prostatectomy (RARP).
• Subjects and their partners/spouses must agree to have no childbearing or sperm donation plans from the screening period to 3 months after the trial completion, and voluntarily adopt effective contraceptive measures.

You may not qualify if:

• Subjects with an allergic diathesis (e.g., a known history of hypersensitivity to two or more drugs), a predisposition to allergic symptoms such as rashes or urticaria, or a known hypersensitivity to the study drug (including its ingredients).
• Subjects with clinically significant abnormal findings in screening tests that are judged by the investigator to affect the study; or those with comorbidities that pose a serious risk to subject safety or interfere with study completion (except for subjects whose conditions are judged by the investigator to be stable for enrollment).
• Subjects who have participated in other clinical trials and received investigational drugs or medical devices within 1 month prior to the administration of the study drug.
• Subjects who have received neoadjuvant therapy, radiotherapy, focal ablation therapy, hormonal therapy, androgen deprivation therapy, or other such treatments in the past 6 months.
• Subjects who are judged by the investigator to be ineligible for the study due to other circumstances.

Sponsors & Collaborators

• Zhu Yinjie: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Jie Yin Zhu, medical doctor degree (MD)

CONTACT

+86 021-5875-2345; yinjiezhu@outlook.com

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: Clinical Professor

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF