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

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.

Eligibility

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.

Conditions2

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