Clinical trial · Interventional
Safety and Efficacy of PSMA-Targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Robot-Assisted Radical Prostatectomy
Phase Ⅱ Clinical Study on the Safety and Efficacy of PSMA-Targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Robot-Assisted Radical Prostatectomy
NCT07415135CI-TRIAL-00103334not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery | Drug | — | UNRESOLVED |
| 0.04 mg/kg of DGPR1008 Injection was administered 24 hours before surgery | Drug | — | UNRESOLVED |
| 0.06 mg/kg of DGPR1008 Injection was administered 24 hours before surgery | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 0.02mg/kg DGPR1008 Injection Dose Group 1 (n=4~10)
- description
- 0.02mg/kg
- interventionNames
- Drug: 0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery
- type
- EXPERIMENTAL
- label
- 0.04mg/kg DGPR1008 Injection Dose Group 1 (n=4~10)
- description
- 0.04mg/kg
- interventionNames
- Drug: 0.04 mg/kg of DGPR1008 Injection was administered 24 hours before surgery
- type
- EXPERIMENTAL
- label
- 0.06mg/kg DGPR1008 Injection Dose Group 1 (n=4~10)
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.