Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Prostate Cancer
NCT07236112 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2026-04-15
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.
Conditions
Interventions
- DRUG
-
Intravenous (IV) single dose
Drug: TRDC002 A single dose of TRDC002 IV. Diagnostic Test: PET/CT imaging.
Sponsors & Collaborators
-
C Ray Therapeutics
lead INDUSTRY
Principal Investigators
-
Yan Wu, MD · C Ray Therapeutics (Chengdu) Co., Ltd.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-08
- Primary Completion
- 2026-04-01
- Completion
- 2026-07-31
- FDA Drug
- Yes
Countries
- China
Study Locations
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