Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:58 PM
Study NCT ID:
NCT07415135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of PSMA-Targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Robot-Assisted Radical Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': '7 days after administration'}, {'measure': '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.', 'timeFrame': '7 days after administration'}], 'secondaryOutcomes': [{'measure': 'To evaluate the proportion of subjects with a positive surgical margin (PSM) of ≥1 as assessed by histopathological examination after radical prostatectomy.', 'timeFrame': '7 days after administration'}, {'measure': 'Number of participants with Adverse events', 'timeFrame': '7 days after administration', 'description': 'Number of participants with Adverse events, with abnormal vital signs assessment, abnormal physical examination findings, abnormal electrocardiogram (ECG) readings, and abnormal laboratory tests including complete blood count (CBC), blood biochemistry, urine routine test, and coagulation function tests'}, {'measure': 'To evaluate the Tumor-to-Background Ratio (TBR)', 'timeFrame': '7 days after administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects with pathologically confirmed prostate cancer via preoperative prostate core needle biopsy who are scheduled to undergo robot-assisted radical prostatectomy (RARP).\n* 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.\n* Male adult subjects aged 18 years or older (inclusive).\n* 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.\n* 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).\n* Subjects judged by the investigator to have no definite surgical contraindications and to be suitable for robot-assisted radical prostatectomy (RARP).\n* 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.\n\nExclusion Criteria:\n\n* 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).\n* 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).\n* 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.\n* Subjects who have received neoadjuvant therapy, radiotherapy, focal ablation therapy, hormonal therapy, androgen deprivation therapy, or other such treatments in the past 6 months.\n* Subjects who are judged by the investigator to be ineligible for the study due to other circumstances."}, 'identificationModule': {'nctId': 'NCT07415135', 'briefTitle': 'Safety and Efficacy of PSMA-Targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Robot-Assisted Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Phase Ⅱ Clinical Study on the Safety and Efficacy of PSMA-Targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Robot-Assisted Radical Prostatectomy', 'orgStudyIdInfo': {'id': 'Zhu Yinjie'}}, 'armsInterventionsModule': {'armGroups': [{'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': '0.06mg/kg', 'interventionNames': ['Drug: 0.06 mg/kg of DGPR1008 Injection was administered 24 hours before surgery']}], 'interventions': [{'name': '0.02 mg/kg of DGPR1008 Injection was administered 24 hours before surgery', 'type': 'DRUG', 'description': '0.02 mg/kg', 'armGroupLabels': ['0.02mg/kg DGPR1008 Injection Dose Group 1 (n=4~10)']}, {'name': '0.04 mg/kg of DGPR1008 Injection was administered 24 hours before surgery', 'type': 'DRUG', 'description': '0.04 mg/kg', 'armGroupLabels': ['0.04mg/kg DGPR1008 Injection Dose Group 1 (n=4~10)']}, {'name': '0.06 mg/kg of DGPR1008 Injection was administered 24 hours before surgery', 'type': 'DRUG', 'description': '0.06 mg/kg', 'armGroupLabels': ['0.06mg/kg DGPR1008 Injection Dose Group 1 (n=4~10)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jie Yin Zhu, medical doctor degree (MD)', 'role': 'CONTACT', 'email': 'yinjiezhu@outlook.com', 'phone': '+86 021-5875-2345'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhu Yinjie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Zhu Yinjie', 'investigatorAffiliation': 'RenJi Hospital'}}}}