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Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Prostate Cancer
Sponsor: C Ray Therapeutics
Summary
TRDC002 uses a radioactive form (64Cu) to trace the PSMA positive prostate cancer. The purpose of this study is to investigate TRDC002 as a PSMA PET tracer to localize PSMA positive lesions in adult patients with recurrent or metastatic prostate cancer. We plan to assess the PSMA PET/CT image quality following administration of two dose levels of TRDC002 to determine an acceptable dose and optimal acquisition time for obtaining diagnostic quality PET/CT images. The safety and tolerability, PK, biodistribution, dosimetry of TRDC002 will also be evaluated in this study.
Official title: A Prospective, Randomized, Open-label, Phase I Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Recurrent or Metastatic Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2026-02-08
Completion Date
2026-07-31
Last Updated
2026-04-15
Healthy Volunteers
No
Conditions
Interventions
Intravenous (IV) single dose
Drug: TRDC002 A single dose of TRDC002 IV. Diagnostic Test: PET/CT imaging.
Locations (2)
Union Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Shandong Cancer Hospital
Jinan, Shandong, China