drugset / Trial / NCT07236112

Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Prostate Cancer

NCT07236112 ↗

Phase 1 Active not recruiting 6 enrolled C Ray Therapeutics
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

EvaluationDrugModalityDoseRoute
Subject TRDC002 Diagnostic / imaging agent 148 mbq Intravenous
Subject TRDC002 Diagnostic / imaging agent 222 mbq Intravenous

Indications