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

A Prospective, Randomized, Open-label, Phase I Study of TRDC002 in the Diagnosis of Patients With PSMA-positive Recurrent or Metastatic Prostate Cancer

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.

This is a prospective, randomized, open-label, phase I study to evaluate safety and tolerability, PK, biodistribution, dosimetry and preliminary efficacy of TRDC002 for PET/CT imaging in participants with PSMA-positive recurrent or metastatic prostate cancer compared with CRS.

At screening, the participants will be assessed for eligibility and will undergo PSMA PET to screen PSMA positive patients.

Eligible participants with recurrent or metastatic prostate cancer will be randomized to receive a single dose of either 4 or 6 mCi of TRDC002 intravenously. Whole-body PET/CT images will be acquired at 1hr, 4hr, 7hr, and 24hr post-injection to observe radiation absorbed dose and pharmacokinetics. Independent review committee (IRC) will evaluate the quality of PET images to determine an acceptable dose and optimal acquisition time for PET scan, and preliminary efficacy compared with Composite Reference Standard (CRS) based on CT/MRI with contrast and bone scan.

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.