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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07236112 on ClinicalTrials.gov