Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Prostate Cancer
NCT ID: NCT07236112
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
6 participants
INTERVENTIONAL
2025-12-25
2026-06-30
Brief Summary
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Detailed Description
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At screening, the participants will be assessed for eligibility and will undergo PSMA PET to screen PSMA positive patients.
Eligible participants with recurrent or metastatic prostate cancer will be randomized to receive a single dose of either 4 or 6 mCi of TRDC002 intravenously. Whole-body PET/CT images will be acquired at 1hr, 4hr, 7hr, and 24hr post-injection to observe radiation absorbed dose and pharmacokinetics. Independent review committee (IRC) will evaluate the quality of PET images to determine an acceptable dose and optimal acquisition time for PET scan, and preliminary efficacy compared with Composite Reference Standard (CRS) based on CT/MRI with contrast and bone scan.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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4 mCi of TRDC002
Patients receive 4±0.5mCi (148±18.5 MBq) of TRDC002 IV. Patients then undergo PET/CT scan.
Intravenous (IV) single dose
Drug: TRDC002 A single dose of TRDC002 IV. Diagnostic Test: PET/CT imaging.
6 mCi of TRDC002
Patients receive 6±0.5mCi (222±18.5 MBq) of TRDC002 IV. Patients then undergo PET/CT scan.
Intravenous (IV) single dose
Drug: TRDC002 A single dose of TRDC002 IV. Diagnostic Test: PET/CT imaging.
Interventions
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Intravenous (IV) single dose
Drug: TRDC002 A single dose of TRDC002 IV. Diagnostic Test: PET/CT imaging.
Eligibility Criteria
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Inclusion Criteria
* Participants with PSMA-positive lesions.
* Participants must have adequate bone marrow and organ function.
* Participants with an ECOG performance status of 0 or 1.
Exclusion Criteria
* A superscan is observed in the baseline bone scan.
* Concurrent serious (as determined by the Investigator) medical conditions
* Participants with symptomatic brain metastases, meningeal metastases, or spinal cord compression.
18 Years
MALE
No
Sponsors
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C Ray Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Yan Wu, MD
Role: STUDY_CHAIR
C Ray Therapeutics (Chengdu) Co., Ltd.
Locations
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Union Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TR1229
Identifier Type: -
Identifier Source: org_study_id
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