Active — Not RecruitingPhase 1

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

China6 participantsStarted 2026-02-08

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants with recurrence or metastasis of prostate cancer. * Participants with PSMA-positive lesions. * Participants must have adequate bone marrow and organ function. * Participants with an ECOG performance status of 0 or 1. Exclusion Criteria: * Any immunotherapy or biological therapy (including antibodies) targeting PSMA within 60 days prior to the day of randomization. * A superscan is observed in the baseline bone scan. * Concurrent serious (as determined by the Investigator) medical conditions * Participants with symptomatic brain metastases, meningeal metastases, or spinal cord compression.

What they're measuring

the safety and tolerability of TRDC002 in participants

Timeframe: 3 days

Trial details

NCT IDNCT07236112

SponsorC Ray Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-01

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