drugset / Trial / NCT07236112
Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Prostate Cancer
RandomizedParallel-groupSingle-blindDiagnostic
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.
Timeline
- Start
- 2026-02-08
- Primary completion
- 2026-04-01
- Completion
- 2026-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TRDC002 | Diagnostic / imaging agent | 148 mbq | Intravenous |
| Subject | TRDC002 | Diagnostic / imaging agent | 222 mbq | Intravenous |